Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340272A, influenza infection, Influenza vaccine
Brief summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
Interventions
BIOLOGICALGSK investigational vaccine GSK2340272A
Two intramuscular injections
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. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * 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; a history of 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 Haemagglutination Inhibition (HI) Antibodies | At Day 21 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% 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. 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. |
| Percentage of Seroconverted (SCR) Subjects for HI Antibodies | At Day 21 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% 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, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 21 and 42 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age. |
| Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 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/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8. |
| Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | At Day 21 and 42 | Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42 | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42 | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42 | 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 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | At Day 0, 21 and 42 | Titres 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. |
| Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | From Day 0 up to Day 42 - Interim analysis posted at Day 42 | An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | 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. |
| Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | At Day 0 and 21 - Interim analysis posted at Day 42 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALAT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[ASAT\], 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 \> 6 years old. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 42-day (Days 0-41) post vaccination period - Interim analysis posted at Day 42 | 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. Note: GSK2340272A 18-60 years (D21) GROUP and GSK2340272A \>60 years (D21) GROUP presents results after the 2 vaccine dose; GSK2340272A 18-60 years (M6) GROUP and GSK2340272A \>60 years (M6) GROUP presents result after 1 vaccine dose. |
| Number of Subjects With Serious Adverse Events (SAEs) | 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. |
| Duration of Solicited General Symptoms Occurring in Response to Individual Doses | During the 7-day (Days 0-6) post-vaccination period following first dose - Interim analysis posted at Day 42 | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 364 | 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. |
| Number of Seroconverted (SCR) Subjects for HI Antibodies | At Day 21 and 42 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% 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. 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
France
Participant flow
Pre-assignment details
Out of 313 subjects enrolled in the study, 7 subjects did not receive any vaccination.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A (D21) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21). | 184 |
| GSK2340272A (M6) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6). | 122 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Withdrawal by Subject | 9 | 9 |
Baseline characteristics
| Characteristic | GSK2340272A (M6) GROUP | Total | GSK2340272A (D21) GROUP |
|---|---|---|---|
| Age, Continuous | 51.6 Years STANDARD_DEVIATION 16 | 52.3 Years STANDARD_DEVIATION 16.5 | 52.8 Years STANDARD_DEVIATION 16.8 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage / African American | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic / North African Heritage | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European Heritage | 114 Participants | 288 Participants | 174 Participants |
| Sex: Female, Male Female | 63 Participants | 155 Participants | 92 Participants |
| Sex: Female, Male Male | 59 Participants | 151 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 122 |
| other Total, other adverse events | 174 / 184 | 117 / 122 |
| serious Total, serious adverse events | 11 / 184 | 8 / 122 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Time frame: At Day 21
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 45.0 Ratio |
| GSK2340272A > 60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 23.4 Ratio |
Primary
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 21
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies | 154 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies | 121 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. 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 According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 156 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 125 Participants |
Primary
Percentage of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 21
Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Percentage of Seroconverted (SCR) Subjects for HI Antibodies | 96.3 Percentage of subjects |
| GSK2340272A > 60 YEARS SUB-GROUP | Percentage of Seroconverted (SCR) Subjects for HI Antibodies | 89.0 Percentage of subjects |
Secondary
Duration of Solicited General Symptoms Occurring in Response to Individual Doses
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 1.5 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 1.5 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.5 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 1.5 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 1.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.5 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 1.0 Days |
Secondary
Duration of Solicited General Symptoms Occurring in Response to Individual Doses
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posed at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, Overall/dose | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, Overall/dose | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, Overall/dose | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 1.5 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, Overall/dose | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, Overall/dose | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 2 | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, Overall/dose | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue, Overall/dose | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 1 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, Overall/dose | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache, Overall/dose | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, post-Dose 2 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, Overall/dose | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating, Overall/dose | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain, Overall/dose | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature, post-Dose 2 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering, post-Dose 1 | 1.0 Days |
Secondary
Duration of Solicited General Symptoms Occurring in Response to Individual Doses
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature | 1.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Temperature | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Fatigue | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Headache | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Joint pain | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Muscle aches | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Sweating | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited General Symptoms Occurring in Response to Individual Doses | Shivering | 1.0 Days |
Secondary
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain | 3.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling | 3.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain | 3.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling | 2.0 Days |
Secondary
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 2 | 2.5 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 1 | 3.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 1 | 2.5 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 2 | 3.0 Days |
| GSK2340272A 18-60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 2 | 3.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 2 | 1.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 1 | 2.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 1 | 3.0 Days |
| GSK2340272A > 60 YEARS SUB-GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 2 | 3.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 1 | 3.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 1 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 2 | 3.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 2 | 2.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 1 | 3.0 Days |
| GSK2340272A 18-60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 2 | 2.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 1 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 1 | 6.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 2 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Pain, post-Dose 1 | 3.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Redness, post-Dose 2 | 4.0 Days |
| GSK2340272A > 60 Years (M6) GROUP | Duration of Solicited Local Symptoms Occurring in Response to Individual Doses | Swelling, post-Dose 2 | 2.0 Days |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Time frame: At Day 21 and 42
Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS 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 | 51.6 Ratio |
| GSK2340272A 18-60 YEARS 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 | 86.7 Ratio |
| GSK2340272A > 60 YEARS 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 | 54.9 Ratio |
| GSK2340272A > 60 YEARS 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 | 23.0 Ratio |
| GSK2340272A 18-60 Years (M6) 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 | 39.2 Ratio |
| GSK2340272A 18-60 Years (M6) 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 | 31.9 Ratio |
| GSK2340272A > 60 Years (M6) 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 | 23.3 Ratio |
| GSK2340272A > 60 Years (M6) 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 | 16.5 Ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Time frame: At Day 182
Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 26.6 Ratio |
| GSK2340272A > 60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 13.4 Ratio |
| GSK2340272A 18-60 Years (M6) GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 14.6 Ratio |
| GSK2340272A > 60 Years (M6) GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 6.1 Ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Time frame: At Day 203
Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 79.0 Ratio |
| GSK2340272A > 60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 65.7 Ratio |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Time frame: At Day 364
Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 11.9 Ratio |
| GSK2340272A > 60 YEARS SUB-GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 4.8 Ratio |
| GSK2340272A 18-60 Years (M6) GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 17.3 Ratio |
| GSK2340272A > 60 Years (M6) GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 8.3 Ratio |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 203
Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 48 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 28 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 21 and 42
Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 21 | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 42 | 86 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 42 | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 21 | 74 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 21 | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 42 | 61 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 21 | 43 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/2009, Day 42 | 39 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 182
Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 72 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 47 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 17 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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 Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 364
Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 60 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 31 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 54 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | 34 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 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 203
Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 48 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 28 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 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 ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS 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 | 11 Participants |
| GSK2340272A 18-60 YEARS 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 | 87 Participants |
| GSK2340272A 18-60 YEARS 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 | 87 Participants |
| GSK2340272A > 60 YEARS 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 | 6 Participants |
| GSK2340272A > 60 YEARS 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 | 83 Participants |
| GSK2340272A > 60 YEARS 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 | 75 Participants |
| GSK2340272A 18-60 Years (M6) 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 | 63 Participants |
| GSK2340272A 18-60 Years (M6) 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 | 10 Participants |
| GSK2340272A 18-60 Years (M6) 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 | 64 Participants |
| GSK2340272A > 60 Years (M6) 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 | 1 Participants |
| GSK2340272A > 60 Years (M6) 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 |
| GSK2340272A > 60 Years (M6) 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 | 46 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 titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. 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 364
Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS 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 > 60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 38 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 56 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 37 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 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 182
Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 83 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 75 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 48 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 19 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.
Time frame: From Day 0 up to Day 364
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)
An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Day 42 - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)
An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Day 364
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 0 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)
An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Day 203 - Interim analysis posted at Day 182/203
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)
An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Day 546
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Any AESI(s) | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) | Related AESI(s) | 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 154 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 18 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 106 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 7 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim Analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 10 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 6 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 11 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 14 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 80 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 91 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 71 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 62 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 11 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 78 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 14 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 10 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 6 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 11 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 91 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 80 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 62 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 11 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 78 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 71 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 10 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 68 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 67 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 54 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 13 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 13 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 35 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 40 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 26 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 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 36 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 46 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 41 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 42 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 43 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 22 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 49 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 14 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 36 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 27 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 8 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 45 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 53 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 34 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 59 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 28 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 40 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 6 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 35 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 18 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 34 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 19 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 24 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 52 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 26 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 32 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 29 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 24 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 39 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 21 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 18 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 53 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 18 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 14 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 29 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 30 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 26 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 20 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 26 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 23 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 27 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 21 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 25 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 13 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 13 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 39 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 27 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 21 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 34 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 28 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 11 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 19 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 20 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 27 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 7 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 40 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 37 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 41 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 16 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 38 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 11 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 31 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 31 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 22 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 31 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 13 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 8 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 13 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 10 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 14 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 10 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 21 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 20 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 24 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 28 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 21 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 8 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 18 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 20 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 31 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 23 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 20 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 16 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 9 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 8 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 10 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 12 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 7 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 17 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 10 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 7 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 9 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 25 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 15 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 5 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 18 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 25 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 20 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 18 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 15 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 7 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 12 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 12 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 15 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 13 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 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 \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 31 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 56 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 56 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 43 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 26 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 56 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 31 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 22 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 19 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 67 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 66 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 13 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 20 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 34 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 29 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 27 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 41 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 44 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 35 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 23 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 18 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 11 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 or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 34 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 40 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 35 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 34 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 30 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 21 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 43 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 36 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 13 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 9 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 48 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 41 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 41 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 36 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 13 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 38 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 31 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 26 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 24 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 19 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 17 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 6 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 59 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 53 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 53 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 46 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 26 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 21 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 53 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 46 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 29 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 24 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 19 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 29 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 25 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 26 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 20 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 23 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 13 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 13 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 27 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 26 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 23 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 13 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 34 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 27 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 39 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 18 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 19 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 30 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 21 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 30 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. Note: GSK2340272A 18-60 years (D21) GROUP and GSK2340272A \>60 years (D21) GROUP presents results after the 2 vaccine dose; GSK2340272A 18-60 years (M6) GROUP and GSK2340272A \>60 years (M6) GROUP presents result after 1 vaccine dose.
Time frame: Within the 42-day (Days 0-41) post vaccination period - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 40 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 11 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 38 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 27 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 5 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 11 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 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.
Time frame: Within the 21-days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 in M6 groups)
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 52 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 53 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 35 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 13 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 16 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 5 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 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.
Time frame: Within 21- days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 21 days post-Dose 2 vaccination (Day 182-203 in M6 groups) - Interim analysis at Day 182/203
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 52 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 53 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 30 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 10 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 15 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 5 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALAT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[ASAT\], bilirubin \[BIL\], creatinine \[CRE\], blood urea nitrogen \[BUN\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and \> 6 years old.
Time frame: At Days 0, 21 and 42 - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 89 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 85 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 88 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 85 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 88 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 83 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 81 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 83 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 88 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 84 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 74 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 11 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 73 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 67 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 86 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 7 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 60 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 24 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 66 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 0 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALAT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[ASAT\], bilirubin \[BIL\], creatinine \[CRE\], blood urea nitrogen \[BUN\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and \> 6 years old.
Time frame: At Day 364
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Within | 82 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Within | 79 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Above | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Within | 81 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Within | 82 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Within | 81 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Above | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Above | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Above | 18 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Above | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Within | 65 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Within | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Within | 77 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Above | 7 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Within | 77 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Within | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Within | 55 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Within | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Above | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Below | 5 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Below | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Within | 59 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Above | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Within | 57 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Below | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Within | 56 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Within | 57 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Above | 5 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Below | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Unknown | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Above | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Within | 46 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Below | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Above | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Within | 45 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Within | 44 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Within | 41 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Above | 7 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP - Within | 45 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT - Above | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT - Above | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN - Within | 37 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALAT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[ASAT\], bilirubin \[BIL\], creatinine \[CRE\], blood urea nitrogen \[BUN\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and \> 6 years old.
Time frame: At Days 0, 21, 42 and 182
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 88 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 88 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 85 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Below | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Within | 81 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Within | 81 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Within | 81 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Below | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Within | 84 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 85 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 87 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 89 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 86 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 83 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 83 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 74 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Within | 76 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Above | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 86 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Within | 81 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 81 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 7 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Above | 6 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Within | 79 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 87 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 82 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 84 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Unknown | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Within | 80 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Above | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 14 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 73 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 11 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 75 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 8 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Within | 76 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Above | 9 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 67 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 22 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 60 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 24 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 66 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 17 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Within | 59 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Above | 24 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 7 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Within | 54 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 60 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 64 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 61 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Within | 59 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Below | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 5 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Within | 57 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Above | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Above | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Above | 10 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 61 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Within | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 7 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Below | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 63 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Below | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Within | 53 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 61 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 2 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 7 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 5 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 64 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 60 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 63 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 65 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 58 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Above | 6 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 63 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 9 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 66 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 64 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 59 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 62 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Within | 59 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 3 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 1 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Above | 4 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Above | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Above | 8 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 42 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 - Above | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Unknown | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Within | 41 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 9 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 - Above | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Above | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 46 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Within | 42 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 45 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Unknown | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 46 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Above | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Within | 47 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Within | 47 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Within | 43 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Within | 36 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Below | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Within | 42 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 - Above | 6 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Above | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Within | 43 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 3 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Below | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 - Unknown | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 50 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Above | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Within | 47 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Within | 49 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 43 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 42 - Above | 2 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Below | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 - Unknown | 1 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Below | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 - Unknown | 0 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 7 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 182 - Within | 44 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 0 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALAT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[ASAT\], 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 \> 6 years old.
Time frame: At Day 0 and 21 - Interim analysis posted at Day 42
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 144 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 4 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 13 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 143 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 12 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 150 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 3 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 8 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 149 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 149 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 10 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 147 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 11 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 153 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 151 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 149 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 7 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 146 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 8 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 2 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 1 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 153 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 5 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 0 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 152 Participants |
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 7 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Within | 102 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Within | 129 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 0 - Above | 12 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Within | 110 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Within | 137 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Below | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Within | 123 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 - Above | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALAT, Day 21 - Above | 14 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Below | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Within | 119 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Within | 135 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Below | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 - Above | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Above | 29 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Within | 132 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Below | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 - Above | 15 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Within | 128 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 - Above | 5 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 - Above | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Above | 33 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Unknown | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Within | 130 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Below | 2 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 0 - Above | 10 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 - Unknown | 0 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Unknown | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Within | 120 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Below | 1 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 - Below | 3 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Within | 125 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 - Above | 21 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ASAT, Day 21 - Above | 10 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.
Time frame: From Day 0 up to Day 546
Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 4 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.
Time frame: From Day 0 up to Day 364
Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| GSK2340272A > 60 YEARS SUB-GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| GSK2340272A 18-60 Years (M6) GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| GSK2340272A > 60 Years (M6) GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09
Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
Time frame: At Day 21 and 42
Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 21 | 75.0 Percentage of subjects |
| GSK2340272A 18-60 YEARS SUB-GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 42 | 100 Percentage of subjects |
| GSK2340272A > 60 YEARS SUB-GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 42 | 87.5 Percentage of subjects |
| GSK2340272A > 60 YEARS SUB-GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 21 | 62.5 Percentage of subjects |
| GSK2340272A 18-60 Years (M6) GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 21 | 84.2 Percentage of subjects |
| GSK2340272A 18-60 Years (M6) GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 42 | 84.2 Percentage of subjects |
| GSK2340272A > 60 Years (M6) GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 21 | 61.1 Percentage of subjects |
| GSK2340272A > 60 Years (M6) GROUP | Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 | Flu A/Netherlands/602/09, Day 42 | 61.1 Percentage of subjects |
Secondary
Titers for Serum 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.
Time frame: At Day 364
Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 107.8 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 35.8 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 155.5 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 68.8 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 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.
Time frame: At Day 203
Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 708.3 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 512.1 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease
Titres 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.
Time frame: At Day 0, 21 and 42
Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 0 | 8.9 Titers |
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 771.8 Titers |
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 459.8 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 0 | 7.3 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 400.9 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 168.2 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 366.1 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 0 | 9.3 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 297.6 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 0 | 8.0 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 132.6 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 187.5 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 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.
Time frame: At Day 182
Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 240.5 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 97.8 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 124.1 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | 48.6 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/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.
Time frame: At Days 0, 21 and 42
Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 42 | 408.2 Titers |
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 21 | 163.0 Titers |
| GSK2340272A 18-60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 0 | 6.0 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 42 | 207.8 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 0 | 10.2 Titers |
| GSK2340272A > 60 YEARS SUB-GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 21 | 96.4 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 0 | 5.5 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 42 | 165.3 Titers |
| GSK2340272A 18-60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 21 | 164.2 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 21 | 168.3 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 42 | 105.0 Titers |
| GSK2340272A > 60 Years (M6) GROUP | Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease | Flu A/Netherlands/602/09, Day 0 | 17.9 Titers |