Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340274A, influenza infection
Brief summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.
Interventions
BIOLOGICALGSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Two intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination. * Written informed consent obtained from the subject's parent(s) or LAR(s) of the subject. Whenever possible, an assent should also be obtained from the subject. * Healthy children as established by medical history and clinical examination when entering into the study (Particular attention must be exercised when dealing with patients with bronchial asthma). * Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device. * Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * Clinically or virologically confirmed influenza infection from May 2009 to the day of enrolment. * Previous administration of a novel \[H1N1\]v vaccine. * Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine. * Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182. * Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation of weight distribution that are corresponding age group are used as reference). * Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * Acute disease and/or fever at the time of enrolment: * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38.0°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). * Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * History of any neurological disorder including acute disseminated encephalomyelitis and Guillain-Barré syndrome, or convulsive seizures and epilepsy. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible * Any conditions which, in the opinion of the investigator, prevents the subject from participating to the study. * Child in Care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value | At Day 42 | The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 42 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Seroconverted Subjects for HI Antibodies | At Day 42 | Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%. |
| Number of Seroprotected Subjects for HI Antibodies | At Day 42 | A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 42 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 42 | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed. |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | At Days 0 and 21 | The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1 | At Day 21 | VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 | At Day 42 | VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain \[child below (\<) 6 years\] = cried when limb was moved/spontaneously painful. Grade 3 pain \[child equal to or above (≥) 6 years\] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | At Days 0 and 21 | The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Up to 84 days (Days 0-83) after the first vaccination | 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 Medically Attended Events (MAEs) | During the entire study period (from Day 0 to Day 182) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. |
| Number of Subjects With Potential Immune-Mediated Diseases (pIMDs) | During the entire study period (from Day 0 to Day 182) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Day 182) | 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 Normal or Abnormal Biochemical Levels | At Days 0, 7 and 42 | Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN). Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. |
| Number of Subjects With Normal or Abnormal Values of Haematological Parameters | At Days 0, 7 and 42 | Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC). Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. |
| Number of Seroconverted Subjects for HI Antibodies | At Day 21 | Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. |
| Number of Seroprotected Subjects for HI Antibodies | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%. |
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 21 | Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK2340274A_F1 6M-9Y Group Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years. | 30 |
| GSK2340274A_F2 10Y-17Y Group Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | GSK2340274A_F1 6M-9Y Group | GSK2340274A_F2 10Y-17Y Group | Total |
|---|---|---|---|
| Age, Continuous | 49.00 Months STANDARD_DEVIATION 27.66 | 163.00 Months STANDARD_DEVIATION 32.41 | 106.00 Months STANDARD_DEVIATION 64.78 |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 30 | 30 / 30 |
| serious Total, serious adverse events | 1 / 30 | 1 / 30 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 146.8 Titers |
| GSK2340274A_F2 10Y-17Y Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 57.1 Titers |
Primary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroconverted Subjects for HI Antibodies | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroconverted Subjects for HI Antibodies | 30 Subjects |
Primary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | 30 Subjects |
Primary
Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value | 30 Subjects |
Primary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 939.3 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 874.3 Titers |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroconverted Subjects for HI Antibodies | 29 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroconverted Subjects for HI Antibodies | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroconverted Subjects for HI Antibodies | 10 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroconverted Subjects for HI Antibodies | 19 Subjects |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroconverted Subjects for HI Antibodies | 27 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroconverted Subjects for HI Antibodies | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroconverted Subjects for HI Antibodies | 9 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroconverted Subjects for HI Antibodies | 18 Subjects |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroconverted Subjects for HI Antibodies | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroconverted Subjects for HI Antibodies | 19 Subjects |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%.
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 29 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 7 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 9 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 1 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 19 Subjects |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 42 | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 42 | 19 Subjects |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 29 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 29 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 8 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 10 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 19 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 1 Subjects |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain \[child below (\<) 6 years\] = cried when limb was moved/spontaneously painful. Grade 3 pain \[child equal to or above (≥) 6 years\] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses (N=24;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses (N=24;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 (N=23;6;30) | 16 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 (N=24;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 (N=24;6;30) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses (N=24;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 (N=24;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses (N=24;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 (N=24;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 (N=24;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 (N=24;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses (N=24;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses (N=24;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses (N=24;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses (N=24;6;30) | 16 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 (N=24;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses (N=24;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 (N=24;6;30) | 14 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses (N=24;6;30) | 5 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses (N=24;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses (N=24;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 (N=24;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 (N=24;6;30) | 7 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 (N=24;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 (N=23;6;30) | 15 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 (N=24;6;30) | 3 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location, muscle aches, shivering, sweating, and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 17 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 14 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 10 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 12 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 16 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 14 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 20 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 19 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 10 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 11 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 8 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 3 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 (N=24) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 (N=24) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 (N=24) | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 (N=24) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 (N=24) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 (N=24) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 (N=24) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 (N=24) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 (N=24) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 (N=24) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 (N=24) | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 (N=24) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 (N=23) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 (N=23) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 (N=23) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 (N=23) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 (N=23) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 (N=23) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 (N=23) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 (N=23) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 (N=23) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 (N=23) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 (N=23) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 (N=23) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses (N=24) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses (N=24) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses (N=24) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses (N=24) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses (N=24) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses (N=24) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses (N=24) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses (N=24) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses (N=24) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses (N=24) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses (N=24) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses (N=24) | 7 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Up to 84 days (Days 0-83) after the first vaccination
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 21 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 8 Subjects |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 182 | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 17 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 182 | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 182 | 9 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 5 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 182 | 19 Subjects |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 9 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 19 Subjects |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 29 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 30 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 18 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 10 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 0 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 5 Subjects |
| GSK2340274A_F1 3Y-9Y Subgroup | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 19 Subjects |
Secondary
Number of Subjects With Medically Attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time frame: During the entire study period (from Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Medically Attended Events (MAEs) | 14 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Medically Attended Events (MAEs) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Medically Attended Events (MAEs) | 10 Subjects |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 (N=29;30) | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 21 (N=29;29) | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 (N=29;30) | 14 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 21 (N=29;29) | 28 Subjects |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 42 | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 | 14 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 42 | 30 Subjects |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 182 | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 0 | 13 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09 H1N1, Day 182 | 29 Subjects |
Secondary
Number of Subjects With Normal or Abnormal Biochemical Levels
Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN). Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Days 0, 7 and 42
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 7 (N=23;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 0 (N=22;6;29) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 42 (N=22;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 42 (N=22;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 0 (N=22;6;29) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 7 (N=23;6;30) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 42 (N=22;6;30) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 42 (N=22;6;30) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 0 (N=22;6;29) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 7 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 42 (N=22;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 42 (N=22;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 7 (N=23;6;30) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 42 (N=22;6;30) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 42 (N=22;6;30) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 42 (N=22;6;30) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 0 (N=22;6;29) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 7 (N=23;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 0 (N=22;6;29) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 7 (N=23;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 42 (N=22;6;30) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 0 (N=22;6;29) | 18 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 42 (N=22;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 42 (N=22;6;30) | 16 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 7 (N=23;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 7 (N=23;6;30) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 0 (N=22;6;29) | 17 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 0 (N=22;6;29) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 7 (N=23;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 42 (N=22;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 7 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 7 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 7 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 7 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 7 (N=23;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 42 (N=22;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Above, Day 42 (N=22;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 42 (N=22;6;30) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 7 (N=23;6;30) | 12 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 0 (N=22;6;29) | 20 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 7 (N=23;6;30) | 18 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Within, Day 42 (N=22;6;30) | 19 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 0 (N=22;6;29) | 11 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 42 (N=22;6;30) | 12 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 0 (N=22;6;29) | 18 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 0 (N=22;6;29) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 42 (N=22;6;30) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Below, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 7 (N=23;6;30) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 7 (N=23;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Within, Day 42 (N=22;6;30) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | CK Above, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | GGT Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Potassium Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Within, Day 42 (N=22;6;30) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | LDH Above, Day 0 (N=22;6;29) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Sodium Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Below, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Within, Day 0 (N=22;6;29) | 25 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Protein Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Within, Day 42 (N=22;6;30) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Urate/Uric acid Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Below, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Within, Day 42 (N=22;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Within, Day 7 (N=23;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Below, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Within, Day 42 (N=22;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Albumin Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | AP Within, Day 0 (N=22;6;29) | 8 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Below, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Within, Day 0 (N=22;6;29) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Bilirubin Conj./Direct Above, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 0 (N=22;6;29) | 9 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Below, Day 42 (N=22;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Cholesterol Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Chloride Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Below, Day 7 (N=23;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 7 (N=23;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Within, Day 42 (N=22;6;30) | 18 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Biochemical Levels | Creatinine Above, Day 42 (N=22;6;30) | 0 Subjects |
Secondary
Number of Subjects With Normal or Abnormal Values of Haematological Parameters
Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC). Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Days 0, 7 and 42
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 0 (N=22;6;29) | 10 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 0 (N=22;6;29) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 7 (N=23;6;30) | 11 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 42 (N=22;6;30) | 15 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 7 (N=23;6;30) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 0 (N=22;6;29) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 7 (N=23;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 42 (N=22;6;30) | 12 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 0 (N=22;6;29) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 7 (N=23;6;30) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 42 (N=22;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 7 (N=23;6;30) | 14 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 42 (N=22;6;30) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 42 (N=22;6;30) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 0 (N=22;6;29) | 16 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 0 (N=22;6;29) | 5 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 7 (N=23;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 42 (N=22;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 0 (N=22;6;29) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 7 (N=23;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 42 (N=22;6;30) | 20 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 0 (N=22;6;29) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 42 (N=22;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 0 (N=22;6;29) | 18 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 0 (N=22;6;29) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 42 (N=22;6;30) | 9 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 7 (N=23;6;30) | 23 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 0 (N=22;6;29) | 15 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 7 (N=23;6;30) | 16 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 42 (N=22;6;30) | 7 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 7 (N=23;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 42 (N=22;6;30) | 12 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 7 (N=23;6;30) | 17 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 0 (N=22;6;29) | 12 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 7 (N=23;6;30) | 13 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 42 (N=22;6;30) | 10 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 0 (N=22;6;29) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 0 (N=22;6;29) | 18 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 42 (N=22;6;30) | 18 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 7 (N=23;6;30) | 21 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 42 (N=22;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 0 (N=22;6;29) | 8 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 7 (N=23;6;30) | 12 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 7 (N=23;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 0 (N=22;6;29) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 7 (N=23;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 0 (N=22;6;29) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 7 (N=23;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 7 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 7 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 7 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 42 (N=22;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 0 (N=22;6;29) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 0 (N=22;6;29) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 42 (N=22;6;30) | 5 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 0 (N=22;6;29) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 7 (N=23;6;30) | 6 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 7 (N=23;6;30) | 25 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 42 (N=22;6;30) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 7 (N=23;6;30) | 5 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 42 (N=22;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 7 (N=23;6;30) | 3 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 7 (N=23;6;30) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 0 (N=22;6;29) | 8 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 7 (N=23;6;30) | 8 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 0 (N=22;6;29) | 20 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 42 (N=22;6;30) | 24 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 42 (N=22;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Within, Day 0 (N=22;6;29) | 23 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | EOS Above, Day 0 (N=22;6;29) | 5 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Below, Day 42 (N=22;6;30) | 4 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 0 (N=22;6;29) | 25 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Within, Day 42 (N=22;6;30) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | HEM Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Below, Day 42 (N=22;6;30) | 6 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Within, Day 7 (N=23;6;30) | 22 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | Hgb Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Within, Day 42 (N=22;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | LYM Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Within, Day 42 (N=22;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | MON Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | BAS Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Below, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | NEU Above, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 0 (N=22;6;29) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 7 (N=23;6;30) | 30 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 0 (N=22;6;29) | 27 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 7 (N=23;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 7 (N=23;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | PLA Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 0 (N=22;6;29) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Below, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 0 (N=22;6;29) | 26 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 7 (N=23;6;30) | 28 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Within, Day 42 (N=22;6;30) | 29 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 0 (N=22;6;29) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 7 (N=23;6;30) | 2 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | RBC Above, Day 42 (N=22;6;30) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 0 (N=22;6;29) | 1 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 7 (N=23;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Unknown, Day 42 (N=22;6;30) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Normal or Abnormal Values of Haematological Parameters | WBC Below, Day 0 (N=22;6;29) | 0 Subjects |
Secondary
Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: During the entire study period (from Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
| GSK2340274A_F1 6M-35M Subgroup | Number of Subjects With Potential Immune-Mediated Diseases (pIMDs) | 0 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 to Day 182)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
Secondary
Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1
VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 | 28 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 | 30 Subjects |
Secondary
Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1
VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 | 27 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1 | 24 Subjects |
Secondary
Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1
VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1 | 15 Subjects |
| GSK2340274A_F2 10Y-17Y Group | Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1 | 17 Subjects |
Secondary
SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 256.0 Titers |
| GSK2340274A_F2 10Y-17Y Group | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 112.8 Titers |
Secondary
SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 25.3 Titers |
| GSK2340274A_F2 10Y-17Y Group | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 23.5 Titers |
| GSK2340274A_F1 6M-35M Subgroup | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 30.8 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 23.1 Titers |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 27.1 Titers |
| GSK2340274A_F2 10Y-17Y Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 22.1 Titers |
| GSK2340274A_F1 6M-35M Subgroup | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 23.5 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 29.3 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 172.0 Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 6.3 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 339.0 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 15.3 Titers |
| GSK2340274A_F1 6M-35M Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | NA Titers |
| GSK2340274A_F1 6M-35M Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 117.3 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 210.4 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 7.2 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 6.4 Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 161.9 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 14.8 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 347.9 Titers |
| GSK2340274A_F1 6M-35M Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | NA Titers |
| GSK2340274A_F1 6M-35M Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 154.0 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 165.8 Titers |
| GSK2340274A_F1 3Y-9Y Subgroup | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 7.2 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | NA Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 1279.9 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 7.2 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 811.3 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 182
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 | 4.9 Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 182 | 149.6 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 | 11.4 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 182 | 213.3 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 | 4.9 Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 42 | 551.1 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 | 11.3 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 42 | 702.4 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 (N=29;30) | 4.9 Titers |
| GSK2340274A_F1 6M-9Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 21 (N=29;29) | 53.8 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 0 (N=29;30) | 11.3 Titers |
| GSK2340274A_F2 10Y-17Y Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09 H1N1, Day 21 (N=29;29) | 121.2 Titers |