Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340274A, Influenza Vaccines, GSK Bio's influenza vaccine GSK2340273A, influenza infection
Brief summary
The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
Detailed description
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Interventions
BIOLOGICALGSK2340274A
One intramuscular injection
BIOLOGICALGSK2340273A
One intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Male and female adults, \>= 18 years of age at the time of the first vaccination. * Satisfactory baseline medical assessment by history and physical examination. * Safety laboratory test results within the parameters specified in the protocol. * Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination; and * has a negative pregnancy test on the day of first 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
* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus. * Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine. * With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0. * Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination. * Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385). * Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus. * 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 a temperature \>= 38.0ºC (\>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment 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 are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible. * History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. * With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0. * Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose. * Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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. * Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination. * Lactating or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 0 | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance. |
| Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | From Day 14 post-vaccination up to study end (at Day 385) | The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. |
| Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | At Day 182 | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. |
| Number of A/California Influenza Related Cases | From Day 0 up to the end of ILI surveillance (Day 385) | Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia. |
| Number of ILI Symptoms in All Reported ILI Cases | From Day 0 up to the end of ILI surveillance (Day 385) | Assessed ILI symptoms were fever \[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | At Days 7 and 21 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[AST\], basophils \[BAS\], total bilirubin \[T/BIL\], bilirubin direct \[BIL/D\], creatinine \[CREA\], eosinophils \[EOS\], hematocrit \[HEM\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], blood urea nitrogen \[BUN\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and \>64 years old (\>64y). |
| Number of Subjects With Any Medically-attended Adverse Events (MAEs) | Throughout the entire study period (Day 0 - Day 385) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Throughout the entire study period (Day 0 - Day 385) | Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 42-day (Days 0-41) post-vaccination period | 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (Day 0 - Day 385) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y). |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK2340274A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. | 2,025 |
| GSK2340273A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. | 2,023 |
| Total | 4,048 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 100 | 96 |
| Overall Study | Migrated/moved from study area | 3 | 6 |
| Overall Study | Others | 3 | 3 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Serious Adverse Event | 5 | 3 |
| Overall Study | Withdrawal by Subject | 31 | 25 |
Baseline characteristics
| Characteristic | GSK2340273A Group | Total | GSK2340274A Group |
|---|---|---|---|
| Age, Continuous | 45.4 Years STANDARD_DEVIATION 18.3 | 45.5 Years STANDARD_DEVIATION 18.4 | 45.5 Years STANDARD_DEVIATION 18.6 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage/African American | 113 Participants | 231 Participants | 118 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan native | 11 Participants | 25 Participants | 14 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 42 Participants | 77 Participants | 35 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 8 Participants | 21 Participants | 13 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese Heritage | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian Heritage | 7 Participants | 15 Participants | 8 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 22 Participants | 48 Participants | 26 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African Heritage | 24 Participants | 43 Participants | 19 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 1790 Participants | 3577 Participants | 1787 Participants |
| Sex: Female, Male Female | 1185 Participants | 2370 Participants | 1185 Participants |
| Sex: Female, Male Male | 838 Participants | 1678 Participants | 840 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 2,025 | 1 / 2,023 |
| other Total, other adverse events | 1,680 / 2,025 | 1,063 / 2,023 |
| serious Total, serious adverse events | 84 / 2,025 | 73 / 2,023 |
Outcome results
Primary
Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
Time frame: From Day 14 post-vaccination up to study end (at Day 385)
Population: The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | 1 Events |
| GSK2340274A (>60 y) Group | Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | 2 Events |
Primary
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1210 Participants |
| GSK2340274A (>60 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 411 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1012 Participants |
| GSK2340273A (>60 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 301 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1279 Participants |
| GSK2340274A (>64 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 342 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1055 Participants |
| GSK2340273A (>64 y) Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 258 Participants |
Primary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 0
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 337 Participants |
| GSK2340274A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 74 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 332 Participants |
| GSK2340273A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 92 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 350 Participants |
| GSK2340274A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 61 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 346 Participants |
| GSK2340273A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 78 Participants |
Primary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1326 Participants |
| GSK2340274A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 470 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1246 Participants |
| GSK2340273A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 371 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1403 Participants |
| GSK2340274A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 393 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1302 Participants |
| GSK2340273A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 315 Participants |
Primary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 27.7 Fold increase |
| GSK2340274A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 12.5 Fold increase |
| GSK2340273A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 15.5 Fold increase |
| GSK2340273A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 6.4 Fold increase |
| GSK2340274A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 26.9 Fold increase |
| GSK2340274A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 11.9 Fold increase |
| GSK2340273A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 14.8 Fold increase |
| GSK2340273A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 6.3 Fold increase |
Secondary
Number of A/California Influenza Related Cases
Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.
Time frame: From Day 0 up to the end of ILI surveillance (Day 385)
Population: The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of A/California Influenza Related Cases | Pneumonia cases | 8 Events |
| GSK2340274A (18-60 y) Group | Number of A/California Influenza Related Cases | Culture confirmed influenza | 1 Events |
| GSK2340274A (18-60 y) Group | Number of A/California Influenza Related Cases | RT-qPCR confirmed influenza | 1 Events |
| GSK2340274A (18-60 y) Group | Number of A/California Influenza Related Cases | RT-qPCR confirmed influenza with pneumonia | 0 Events |
| GSK2340274A (18-60 y) Group | Number of A/California Influenza Related Cases | ILI cases | 195 Events |
| GSK2340274A (>60 y) Group | Number of A/California Influenza Related Cases | RT-qPCR confirmed influenza with pneumonia | 0 Events |
| GSK2340274A (>60 y) Group | Number of A/California Influenza Related Cases | ILI cases | 234 Events |
| GSK2340274A (>60 y) Group | Number of A/California Influenza Related Cases | Pneumonia cases | 21 Events |
| GSK2340274A (>60 y) Group | Number of A/California Influenza Related Cases | RT-qPCR confirmed influenza | 2 Events |
| GSK2340274A (>60 y) Group | Number of A/California Influenza Related Cases | Culture confirmed influenza | 2 Events |
Secondary
Number of ILI Symptoms in All Reported ILI Cases
Assessed ILI symptoms were fever \[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
Time frame: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
Population: The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Sore throat | 93 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Headache | 93 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Cough | 99 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Vomiting | 21 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Runny or stuffy nose | 99 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Diarrhea | 28 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Myalgia | 104 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Chills | 76 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Short of breath | 46 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fatigue | 102 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fever | 45 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fatigue | 132 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fever | 51 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Myalgia | 128 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Cough | 127 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Sore throat | 129 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Runny or stuffy nose | 119 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Short of breath | 50 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Headache | 122 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Vomiting | 16 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Diarrhea | 32 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Chills | 96 Events |
Secondary
Number of ILI Symptoms in All Reported ILI Cases
Assessed ILI symptoms were fever \[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
Time frame: From Day 0 up to the end of ILI surveillance (Day 385)
Population: The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Myalgia | 109 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Runny or stuffy nose | 103 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fever | 47 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Short of breath | 48 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Cough | 104 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Headache | 97 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Diarrhea | 30 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Chills | 80 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Sore throat | 98 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fatigue | 106 Events |
| GSK2340274A (18-60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Vomiting | 23 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fatigue | 146 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Vomiting | 20 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Headache | 134 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Fever | 58 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Myalgia | 140 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Cough | 138 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Sore throat | 140 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Runny or stuffy nose | 132 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Short of breath | 54 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Diarrhea | 35 Events |
| GSK2340274A (>60 y) Group | Number of ILI Symptoms in All Reported ILI Cases | Chills | 104 Events |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 823 Participants |
| GSK2340274A (>60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 198 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 717 Participants |
| GSK2340273A (>60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 146 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 861 Participants |
| GSK2340274A (>64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 160 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 741 Participants |
| GSK2340273A (>64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 122 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 49 Participants |
| GSK2340274A (>60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 36 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 35 Participants |
| GSK2340273A (>60 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 20 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 51 Participants |
| GSK2340274A (>64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 34 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 36 Participants |
| GSK2340273A (>64 y) Group | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 19 Participants |
Secondary
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1282 Participants |
| GSK2340274A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 501 Participants |
| GSK2340273A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1257 Participants |
| GSK2340273A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 449 Participants |
| GSK2340274A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1361 Participants |
| GSK2340274A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 422 Participants |
| GSK2340273A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 1324 Participants |
| GSK2340273A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 382 Participants |
Secondary
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 754 Participants |
| GSK2340274A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 1348 Participants |
| GSK2340274A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 293 Participants |
| GSK2340274A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 534 Participants |
| GSK2340273A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 731 Participants |
| GSK2340273A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 1335 Participants |
| GSK2340273A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 312 Participants |
| GSK2340273A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 512 Participants |
| GSK2340274A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 803 Participants |
| GSK2340274A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 1430 Participants |
| GSK2340274A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 244 Participants |
| GSK2340274A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 452 Participants |
| GSK2340273A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 1410 Participants |
| GSK2340273A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 775 Participants |
| GSK2340273A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 268 Participants |
| GSK2340273A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 437 Participants |
Secondary
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 50 Participants |
| GSK2340274A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 50 Participants |
| GSK2340273A (18-60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 44 Participants |
| GSK2340273A (>60 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 45 Participants |
| GSK2340274A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 52 Participants |
| GSK2340274A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 48 Participants |
| GSK2340273A (18-64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 46 Participants |
| GSK2340273A (>64 y) Group | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 43 Participants |
Secondary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 49 Participants |
| GSK2340274A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 38 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 41 Participants |
| GSK2340273A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 29 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 51 Participants |
| GSK2340274A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 36 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 43 Participants |
| GSK2340273A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 27 Participants |
Secondary
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1091 Participants |
| GSK2340274A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 286 Participants |
| GSK2340273A (18-60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1009 Participants |
| GSK2340273A (>60 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 236 Participants |
| GSK2340274A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1140 Participants |
| GSK2340274A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 237 Participants |
| GSK2340273A (18-64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 1047 Participants |
| GSK2340273A (>64 y) Group | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | 198 Participants |
Secondary
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: Throughout the entire study period (Day 0 - Day 385)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 3 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 3 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 137 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 55 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 89 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 1256 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 272 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 25 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 28 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 458 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 10 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 11 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 45 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 24 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 106 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 205 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 157 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 359 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 130 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 23 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 16 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 242 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 81 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 7 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 12 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 382 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 531 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 19 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 452 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 25 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 473 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 1 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 4 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 600 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 73 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 7 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 84 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 53 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 52 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 43 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 93 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 79 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 23 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 63 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 17 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 298 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 281 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 18 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 16 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 76 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 9 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 76 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 421 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 7 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 240 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 59 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 135 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 361 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 3 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 6 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 312 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 14 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 7 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 112 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 94 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 26 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 59 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 48 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 55 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 43 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 27 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 23 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 35 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 17 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 14 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 5 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 2 Participants |
Secondary
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: Throughout the entire study period (Day 0 - Day 385)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 615 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 247 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 614 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 265 Participants |
Secondary
Number of Subjects With Any 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: Within the 42-day (Days 0-41) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 495 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 119 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 522 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 139 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[AST\], basophils \[BAS\], total bilirubin \[T/BIL\], bilirubin direct \[BIL/D\], creatinine \[CREA\], eosinophils \[EOS\], hematocrit \[HEM\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], blood urea nitrogen \[BUN\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and \>64 years old (\>64y).
Time frame: At Days 7 and 21
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Within | 1505 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Above | 10 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 14 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 1466 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Within | 1511 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Within | 1458 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Within | 1511 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Above | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Within | 1467 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Above | 17 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Within | 1524 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Within | 1484 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Below | 149 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Within | 1365 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Above | 10 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Below | 150 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Within | 1324 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Above | 10 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Below | 64 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Within | 1411 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Above | 36 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Below | 63 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Within | 1345 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Above | 50 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Unknown | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Below | 72 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Within | 1429 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Above | 12 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Unknown | 29 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Below | 88 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Within | 1368 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Above | 8 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Unknown | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Within | 1497 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Above | 27 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 1455 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 29 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Below | 1 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Within | 1497 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Above | 26 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 2 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 1461 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 21 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Unknown | 12 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Below | 47 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Within | 1455 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Above | 11 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Unknown | 29 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Below | 58 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Within | 1399 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Above | 7 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Below | 5 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Within | 1494 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Above | 12 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Below | 7 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Within | 1445 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Above | 6 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Below | 306 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Within | 1205 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Below | 309 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Within | 1149 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Above | 0 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Below | 42 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Within | 1449 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Above | 16 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Below | 48 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Unknown | 30 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Within | 1392 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Above | 18 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Below | 6 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Within | 1498 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Above | 7 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Below | 7 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Within | 1454 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Above | 2 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Unknown | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Below | 97 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Within | 1411 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Above | 5 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Unknown | 29 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Below | 95 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Within | 1368 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Above | 1 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Unknown | 3 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Below | 5 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Within | 1509 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Above | 10 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 9 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 1462 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 13 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Below | 27 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Unknown | 15 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Within | 1457 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Above | 27 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Unknown | 35 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Below | 31 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Within | 1406 Participants |
| GSK2340274A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Above | 21 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Within | 475 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Within | 427 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Above | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Below | 18 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 463 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Below | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Above | 16 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Above | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Within | 454 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Unknown | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Above | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Below | 9 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 467 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Below | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Within | 465 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Within | 443 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Within | 404 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Unknown | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Above | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Within | 473 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Below | 58 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Unknown | 9 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Within | 468 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Below | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Below | 11 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Below | 7 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Within | 460 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Within | 417 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Below | 54 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Within | 463 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Within | 471 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Below | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Above | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Within | 466 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Within | 463 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Above | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Above | 2 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Above | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Within | 454 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Below | 7 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Above | 7 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Within | 465 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Unknown | 9 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Below | 12 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Within | 475 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Below | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Below | 37 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Below | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Within | 451 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Unknown | 11 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Within | 463 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Above | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Above | 3 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Below | 35 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Within | 437 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Unknown | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Below | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Unknown | 9 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Within | 471 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Unknown | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Above | 22 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Above | 7 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Within | 471 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Within | 478 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Within | 448 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Within | 431 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Unknown | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Above | 6 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 469 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Above | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Below | 8 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 4 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Unknown | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Above | 5 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Below | 10 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 472 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Unknown | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 0 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Below | 20 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Within | 463 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Above | 1 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Within | 455 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Above | 15 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Within | 456 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Within | 440 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Within | 455 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Unknown | 14 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Below | 30 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Above | 11 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Within | 1448 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Unknown | 3 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Below | 136 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Within | 1345 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Above | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Above | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Below | 66 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Within | 1398 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Within | 1414 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Above | 35 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Within | 1361 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Below | 60 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Above | 39 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Below | 102 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Below | 82 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Within | 1440 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Within | 1416 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Above | 17 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Within | 1402 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Unknown | 29 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Below | 91 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Within | 1362 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Above | 10 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Above | 11 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Within | 1482 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Unknown | 29 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Above | 37 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 1437 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 51 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Below | 90 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Above | 45 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Within | 1495 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Above | 23 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Within | 1367 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 1469 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 19 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Within | 1363 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Below | 65 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Within | 1436 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Above | 14 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Unknown | 28 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Below | 68 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Below | 9 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Within | 1385 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Above | 11 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Below | 7 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Within | 1500 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Within | 1500 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Above | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Below | 2 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Above | 9 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Within | 1444 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Above | 14 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Below | 290 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Within | 1224 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Above | 1 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Below | 304 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Within | 1155 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Above | 1 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Below | 30 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Below | 39 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 1467 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Within | 1448 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Above | 27 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Above | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Below | 53 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 16 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Within | 1493 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Above | 17 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Within | 1392 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 6 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 1459 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 27 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Above | 15 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Within | 1515 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Above | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Unknown | 32 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Within | 1460 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Above | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Below | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Within | 1500 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Above | 19 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Within | 1501 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Unknown | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Unknown | 8 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Within | 1466 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Above | 22 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Above | 6 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Above | 6 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Within | 1518 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Above | 1 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Unknown | 4 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Unknown | 29 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Below | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Within | 1488 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Above | 0 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Unknown | 5 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Below | 11 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Below | 144 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Within | 438 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Above | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Within | 458 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Below | 16 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Within | 473 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Above | 7 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Within | 468 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Above | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Below | 12 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Within | 448 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Below | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Within | 443 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 468 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 469 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Below | 32 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Above | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Above | 18 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Above | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Within | 456 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Within | 477 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Within | 472 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Within | 475 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 7 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Within | 444 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Within | 449 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Unknown | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Below | 30 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Within | 453 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 7 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Within | 466 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Within | 458 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Below | 9 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Below | 10 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BAS, Day 21 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Below | 7 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Within | 469 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Below | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Below | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Within | 452 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Above | 9 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Within | 466 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Within | 472 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 21 | Above | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Within | 468 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Below | 7 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | LYM, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Within | 467 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Below | 52 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 7 | Above | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Within | 423 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Within | 456 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 7 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Below | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Below | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 7 | Unknown | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 21 | Unknown | 10 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Below | 64 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Within | 470 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | PLA, Day 7 | Within | 467 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Within | 402 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Below | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 7 | Below | 6 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | MON, Day 21 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 21 | Above | 3 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Above | 12 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Below | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HgB, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 7 | Unknown | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CREA, Day 7 | Above | 2 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Below | 11 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | RBC, Day 21 | Above | 0 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | HEM, Day 7 | Unknown | 1 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Within | 459 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 469 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 9 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL/D, Day 21 | Within | 473 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 7 | Above | 4 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 21 | Below | 10 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 464 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | T/BIL, Day 21 | Within | 467 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Unknown | 8 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Above | 13 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | WBC, Day 7 | Above | 7 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | EOS, Day 21 | Within | 437 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | NEU, Day 21 | Below | 12 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).
Time frame: Throughout the entire study period (Day 0 - Day 385)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 45 Participants |
| GSK2340274A (>60 y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 39 Participants |
| GSK2340273A (18-60 y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 32 Participants |
| GSK2340273A (>60 y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 41 Participants |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 7.7 Fold increase |
| GSK2340274A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 3.5 Fold increase |
| GSK2340273A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 5.9 Fold increase |
| GSK2340273A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 2.5 Fold increase |
| GSK2340274A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 7.5 Fold increase |
| GSK2340274A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 3.4 Fold increase |
| GSK2340273A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 5.6 Fold increase |
| GSK2340273A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | 2.5 Fold increase |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
Time frame: At Day 42
Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 26.8 Fold increase |
| GSK2340274A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 11.1 Fold increase |
| GSK2340273A (18-60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 13.7 Fold increase |
| GSK2340273A (>60 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 4.0 Fold increase |
| GSK2340274A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 26.1 Fold increase |
| GSK2340274A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 11.0 Fold increase |
| GSK2340273A (18-64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 13.2 Fold increase |
| GSK2340273A (>64 y) Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 3.9 Fold increase |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 14.9 Titers |
| GSK2340274A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 415.0 Titers |
| GSK2340274A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 11.0 Titers |
| GSK2340274A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 135.9 Titers |
| GSK2340273A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 14.8 Titers |
| GSK2340273A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 228.7 Titers |
| GSK2340273A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 12.2 Titers |
| GSK2340273A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 77.3 Titers |
| GSK2340274A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 14.7 Titers |
| GSK2340274A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 396.2 Titers |
| GSK2340274A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 10.9 Titers |
| GSK2340274A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 128.6 Titers |
| GSK2340273A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 217.6 Titers |
| GSK2340273A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 14.7 Titers |
| GSK2340273A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 0 | 12.0 Titers |
| GSK2340273A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Flu A/CAL/7/09, Day 21 | 75.2 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 288.5 Titers |
| GSK2340274A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 105.4 Titers |
| GSK2340273A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 177.2 Titers |
| GSK2340273A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 47.9 Titers |
| GSK2340274A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 276.5 Titers |
| GSK2340274A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 105.9 Titers |
| GSK2340273A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 170.0 Titers |
| GSK2340273A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 47.2 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 115.5 Titers |
| GSK2340274A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 38.4 Titers |
| GSK2340273A (18-60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 87.6 Titers |
| GSK2340273A (>60 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 30.1 Titers |
| GSK2340274A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 109.5 Titers |
| GSK2340274A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 37.1 Titers |
| GSK2340273A (18-64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 83.3 Titers |
| GSK2340273A (>64 y) Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | 29.2 Titers |