Tuberculosis
Conditions
Keywords
Tuberculosis vaccine
Brief summary
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK Biologicals' AS01B adjuvant
Intramuscular injection, 2 doses
BIOLOGICALGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1
Intramuscular injection, 2 doses
BIOLOGICALGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
Intramuscular injection, 2 doses
BIOLOGICALGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3
Intramuscular injection, 2 doses
BIOLOGICALGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1
Intramuscular injection, 2 doses
BIOLOGICALGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2
Intramuscular injection, 2 doses
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 45 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to any study procedure. * Free of obvious health problems as established by medical history and clinical examination before enrolment into the study. * If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. * No evidence of pulmonary pathology as confirmed by chest X-ray. * No history of extrapulmonary TB. * Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis. * Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies. * Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs. * History of previous administration of experimental Mycobacterium tuberculosis vaccines. * History of previous exposure to experimental products containing MPL or QS21. * Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * A family history (first generation) of congenital or hereditary immunodeficiency. * History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. * History of any neurological disorders or seizures. * History of allergic reactions or anaphylaxis to previous immunisations. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * History of chronic alcohol consumption and/or drug abuse. * Major congenital defects. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Different Biochemical and Haematological Levels | At Day 0 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above. |
| Number of Subjects With Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses | Assessed solicited general symptoms included fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 210) | 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. |
| Number of Subjects With Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses | Assessed solicited local symptoms included 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 50 millimeters (mm) of injection site. Relationship analysis was not performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | At Day 0, 30, 60 and 210 | Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines. |
| Anti-M72 Specific Antibody Concentrations | At Day 0, 30, 60 and 210 | Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs). |
| Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | At Day 0, 30, 60 and 210 | Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS). |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 10 |
| GSK692342_F1 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 10 |
| GSK692342_F2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 40 |
| GSK692342_F3 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 40 |
| GSK692342_F4D1 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 40 |
| GSK692342_F4D2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. | 40 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Migrated/moved from study area | 1 | 0 | 1 | 1 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Control Group | GSK692342_F1 Group | GSK692342_F2 Group | GSK692342_F3 Group | GSK692342_F4D1 Group | GSK692342_F4D2 Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.1 Years STANDARD_DEVIATION 8.1 | 36.0 Years STANDARD_DEVIATION 5.14 | 30.6 Years STANDARD_DEVIATION 9.14 | 33.5 Years STANDARD_DEVIATION 8.73 | 30.6 Years STANDARD_DEVIATION 9.17 | 31.5 Years STANDARD_DEVIATION 8.83 | 31.92 Years STANDARD_DEVIATION 8.67 |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 33 Participants | 36 Participants | 31 Participants | 26 Participants | 142 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 7 Participants | 4 Participants | 9 Participants | 14 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 9 / 10 | 40 / 40 | 39 / 40 | 39 / 40 | 38 / 40 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 2 / 40 | 0 / 40 | 2 / 40 | 0 / 40 |
Outcome results
Primary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 2 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 4 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 6 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 33 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 33 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 6 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 33 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 32 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 7 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 7 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 33 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 5 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 32 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 34 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 6 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 31 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 34 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 33 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 34 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 33 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 31 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
Primary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time frame: At Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 4 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 6 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 35 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 13 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 27 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 4 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 34 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 5 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 34 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 11 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 28 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 6 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 9 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 30 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
Primary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time frame: At Day 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 7 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 2 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 34 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 33 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 35 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 34 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 32 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 4 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 31 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 31 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 5 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 34 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 7 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
Primary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time frame: At Day 37
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 8 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 4 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 6 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 4 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 2 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 6 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 4 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 6 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 34 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 34 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 35 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 32 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 15 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 25 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 34 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 4 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 32 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 34 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 35 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 5 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 4 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 6 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 33 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 5 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 33 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 34 Subjects |
Primary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 7 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 1 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 3 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 10 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 9 Subjects |
| Control Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 8 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 7 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 10 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 35 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 40 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 29 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 39 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 11 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 40 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 37 Subjects |
| GSK692342_F2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 9 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 4 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 35 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 4 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 31 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 22 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 36 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 40 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 39 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 18 Subjects |
| GSK692342_F3 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 40 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 36 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 38 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 9 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 30 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Above | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Above | 5 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Below | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Normal | 35 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Below | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hct, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Normal | 34 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Below | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Above | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Normal | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Missing | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Below | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Normal | 38 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Missing | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Missing | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Below | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | CREA, Normal | 39 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | WBC, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Above | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Above | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Missing | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Below | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Above | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Normal | 37 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Different Biochemical and Haematological Levels | Hgb, Normal | 36 Subjects |
Primary
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.
Time frame: During the entire study period (from Day 0 up to Day 210)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms included fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. 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.
Time frame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 4 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 2 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 5 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 4 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 3 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 4 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 6 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 11 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 14 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 9 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 22 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 13 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 21 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 13 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 18 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 25 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 15 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 9 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 3 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 22 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 18 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 18 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 15 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 8 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 4 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 25 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 23 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 22 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 24 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 17 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 25 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 22 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 7 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 17 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 9 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 7 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 10 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 8 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 21 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 8 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 23 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 9 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 21 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 20 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 20 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 8 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 7 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 8 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 16 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 21 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 15 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 13 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 27 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 8 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 15 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 11 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 5 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 9 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 10 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 23 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 13 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 15 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 11 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 3 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 16 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 23 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 21 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 29 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 24 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 21 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 24 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 23 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 6 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 24 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 4 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 8 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 15 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 24 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 17 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 2 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 23 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 13 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 30 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Across | 10 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Across | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 1 | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Across | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Across | 26 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 27 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Across | 4 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 26 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Across | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 23 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 9 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 13 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Across | 26 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 29 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 1 | 16 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Across | 28 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 14 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 1 | 7 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Gastro, Dose 2 | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 28 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 19 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 28 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 29 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Malaise, Dose 2 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro, Dose 2 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 27 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Across | 28 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 2 | 25 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 22 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 10 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 26 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 7 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Malaise, Dose 1 | 18 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Any Gastro, Dose 2 | 9 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 10 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited General Symptoms | Related Malaise, Dose 2 | 24 Subjects |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms included 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 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Time frame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 7 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 9 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 3 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 4 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 5 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 2 Subjects |
| GSK692342_F1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 5 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 35 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 8 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 33 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 38 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| GSK692342_F2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 10 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 3 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 32 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 5 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 37 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 10 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 1 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 0 Subjects |
| GSK692342_F3 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 37 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 6 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 4 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 12 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 4 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 33 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 12 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 5 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 3 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 32 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 36 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 1 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Subjects |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 7 Subjects |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Subjects |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
| GSK692342_F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Subjects |
| GSK692342_F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 9 Subjects |
| GSK692342_F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Subjects |
| GSK692342_F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 7 Subjects |
| GSK692342_F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 29 Subjects |
| GSK692342_F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 2 Subjects |
| GSK692342_F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 33 Subjects |
| GSK692342_F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 33 Subjects |
| GSK692342_F4D1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 5 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 2 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 27 Subjects |
| GSK692342_F4D2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
Secondary
Anti-M72 Specific Antibody Concentrations
Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| Control Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 2.9 EL.U/mL |
| GSK692342_F1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 31.0 EL.U/mL |
| GSK692342_F1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 6.1 EL.U/mL |
| GSK692342_F2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 4.9 EL.U/mL |
| GSK692342_F2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 458.4 EL.U/mL |
| GSK692342_F2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 51.1 EL.U/mL |
| GSK692342_F3 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 46.3 EL.U/mL |
| GSK692342_F3 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 5.5 EL.U/mL |
| GSK692342_F3 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F3 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 468.5 EL.U/mL |
| GSK692342_F4D1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 598.6 EL.U/mL |
| GSK692342_F4D1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 70.7 EL.U/mL |
| GSK692342_F4D1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F4D1 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 8.7 EL.U/mL |
| GSK692342_F4D2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D30 [N=10;10;39;38;40;39] | 15.0 EL.U/mL |
| GSK692342_F4D2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D60 [N=10;10;39;38;40;39] | 833.0 EL.U/mL |
| GSK692342_F4D2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D0 [N=10;10;39;38;40;39] | 1.4 EL.U/mL |
| GSK692342_F4D2 Group | Anti-M72 Specific Antibody Concentrations | Anti-M72, D210 [N=9;10;38;36;39;36] | 85.2 EL.U/mL |
Secondary
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 218.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 87.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 188.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 114.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 107.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 206.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 146.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 134.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 104.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 72.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 120.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 111.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 73.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 146.0 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 185.5 T cells/million cells |
| Control Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 78.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 853.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 907.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 227.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 1427.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 333.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 1374.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 1773.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 258.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 220.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 626.5 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 1046.5 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 933.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 1986.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 733.5 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 1014.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 1106.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 1934.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 3070.5 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 5413.5 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 1907.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 3727.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 147.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 173.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 2560.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 5704.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 3240.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 143.5 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 2028.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 1477.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 3993.5 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 2960.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 180.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 180.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 193.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 2813.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 1280.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 1140.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 1831.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 151.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 938.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 927.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 2424.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 3068.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 224.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 1233.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 2086.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 2180.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 1460.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 3080.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 177.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 202.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 3173.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 1534.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 233.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 4384.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 3019.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 2334.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 1097.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 2305.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 1413.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 4460.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 210.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 2520.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 2016.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D210 [N=9;7;37;32;35;34] | 1711.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D0 [N=9;9;38;34;40;39] | 261.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D30 [N=10;10;38;36;39;37] | 3213.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D60 [N=10;9;38;36;38;37] | 4680.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-CD40-L, D210 [N=9;7;37;32;35;34] | 3540.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IL-2, D0 [N=9;9;38;34;40;39] | 226.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D30 [N=10;10;38;36;39;37] | 3120.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D60 [N=10;9;38;36;38;37] | 4414.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IL-2, D210 [N=9;7;37;32;35;34] | 3533.5 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-TNF-α, D0 [N=9;9;38;34;40;39] | 160.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D30 [N=10;10;38;36;39;37] | 2133.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D60 [N=10;9;38;36;38;37] | 2867.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-TNF-α, D210 [N=9;7;37;32;35;34] | 2580.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD40-IFN-γ, D0 [N=9;9;38;34;40;39] | 306.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D30 [N=10;10;38;36;39;37] | 1733.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | CD4-IFN-γ, D60 [N=10;9;38;36;38;37] | 2453.0 T cells/million cells |
Secondary
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).
Time frame: At Day 0, 30, 60 and 210
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 173.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 9.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 31.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 1.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 1.0 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 245.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 139.5 T cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 106.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 16.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 1426.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 2133.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 20.5 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 5.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 293.0 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 1013.5 T cells/million cells |
| GSK692342_F1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 1.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 1.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 39.5 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 200.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 1.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 2833.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 6307.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 3826.0 T cells/million cells |
| GSK692342_F2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 17.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 241.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 2486.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 1653.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 1.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 14.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 33.0 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 3855.5 T cells/million cells |
| GSK692342_F3 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 10.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 26.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 4880.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 263.5 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 2653.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 3240.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 9.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 59.0 T cells/million cells |
| GSK692342_F4D1 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 54.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D30 [N=10;10;38;36;39;37] | 3280.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D210 [N=9;7;37;32;35;34] | 24.5 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D60 [N=10;9;38;36;38;37] | 16.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D0 [N=9;9;38;34;40;39] | 312.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D210 [N=9;7;37;32;35;34] | 3633.5 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD4-All Doubles, D60 [N=10;9;38;36;38;37] | 5133.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D30 [N=10;10;38;36;39;37] | 34.0 T cells/million cells |
| GSK692342_F4D2 Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | CD8-All Doubles, D0 [N=9;9;38;34;40;39] | 18.0 T cells/million cells |