Haemophilus Influenzae, Streptococcus Pneumoniae
Conditions
Keywords
Non-typable Haemophilus influenzae, protein vaccine, Streptococcus pneumoniae, young adults
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.
Detailed description
This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.
Interventions
BIOLOGICALGSK2231395A
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.
BIOLOGICALEngerix-B
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 40 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Subject without medical history, clinical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol. * If the subject is female, and of childbearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.
Exclusion criteria
* Pneumonia within 3 years prior to 1st vaccination. * Invasive Pneumococcal Disease within 3 years prior to 1st vaccination. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines, with the exception of the influenza vaccine which can be administered \>14 days prior to or \>14 days following vaccine doses 1 and 2. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * History of reaction or hypersensitivity to any component of the vaccine. * Any serious, uncontrolled disease likely to interfere with the study as determined by history, physical examination or laboratory screening, as per the judgment of the Investigator. * Inflammatory processes such as known chronic infections. * All past or current malignancies and lymphoproliferative disorders. * Laboratory evidence of haematological and biochemical abnormalities. * Acute disease at the time of enrolment/vaccination. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Other conditions that the principal investigator judges may interfere with study findings. * Previous vaccination for hepatitis B. As a portion of the subjects will be randomized to receive Engerix-B comparator, it is important that all subjects meet Engerix-B eligibility criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Hematological Laboratory Abnormalities | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. | Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3. |
| Number of Subjects With Any Unsolicited Adverse Events (AE) | During a 30-day (Days 0-29) follow up period after any vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From Day 0 to Day 420 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Any Biochemical Laboratory Abnormalities | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420 | Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE). Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3. |
| Number of Subjects With Any Solicited Local and General Symptoms | During a 7-day follow up period after any vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade. Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. | The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations: Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17. |
| Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. | The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations: C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17). |
| Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Days 0, 30, 60, 90, 180 and 420. | Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK2254233A Group Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 15 |
| GSK2254232A Group Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 17 |
| Engerix Group Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 8 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK2254233A Group | GSK2254232A Group | Engerix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 26.9 Years STANDARD_DEVIATION 5.91 | 24.3 Years STANDARD_DEVIATION 3.69 | 26.6 Years STANDARD_DEVIATION 5.5 | 25.7 Years STANDARD_DEVIATION 5.01 |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 15 | 17 / 17 | 8 / 8 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 | 0 / 8 |
Outcome results
Primary
Number of Subjects With Any Biochemical Laboratory Abnormalities
Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE). Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Pre Dose 1 (Day 0) [N=2,2,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 180) [N=14,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Pre Dose 1 (Day 0) [N=2,2,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 180) [N=14,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 2 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 180) [N=15,17,7] | 2 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Pre Dose 1 (Day 0) [N=2,2,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 or 3 (Day 300) [N=15,16,5] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 180) [N=14,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 or 3 (Day 300) [N=15,16,6] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | URE, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | CREA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | AST, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Biochemical Laboratory Abnormalities | ALT, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
Primary
Number of Subjects With Any Hematological Laboratory Abnormalities
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3.
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 67) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 2 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 7) [N=15,17,8] | 2 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 7) [N=15,17,8] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 7) [N=15,17,8] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 67) [N=15,17,7] | 3 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 67) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 67) [N=15,17,7] | 1 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 7) [N=15,17,8] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 60) [N=15,17,7] | 4 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 67) [N=15,17,7] | 2 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 180) [N=15,17,7] | 2 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 2 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 180) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 67) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Pre Dose 1 (Day 0) [N=2,3,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 180) [N=15,17,7] | 1 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 67) [N=15,17,7] | 1 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 60) [N=15,17,7] | 2 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 (Day 180) [N=15,17,7] | 1 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 1 (Day 7) [N=15,17,8] | 1 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 1 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 1 (Day 60) [N=15,17,7] | 1 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC Low, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | RBC, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 0) [N=2,3,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | WBC High, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | HEM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | PLA, Pre Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
Primary
Number of Subjects With Any Hematological Laboratory Abnormalities
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254233A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Pre Dose 1 (Day 0) [N=2,4,0] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | EOS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Pre Dose 1 (Day 0) [N=2,4,0] | NA Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 7) [N=15,17,8] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | BAS, Post Dose 2 (Day 180) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | LYM, Post Dose 2 or 3 (Day 420) [N=14,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | NEU, Post Dose 2 (Day 67) [N=15,17,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 2 or 3 (Day 300) [N=15,16,7] | 0 Subjects |
| Engerix Group | Number of Subjects With Any Hematological Laboratory Abnormalities | MON, Post Dose 1 (Day 60) [N=15,17,7] | 0 Subjects |
Primary
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 to Day 420
Population: The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Subjects |
| GSK2254232A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Subjects |
| Engerix Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Subjects |
Primary
Number of Subjects With Any Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade. Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.
Time frame: During a 7-day follow up period after any vaccination
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any fatigue | 12 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any temperature | 10 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any headache | 11 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any gastrointestinal | 4 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any pain | 15 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any myalgia | 13 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any swelling | 6 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any redness | 10 Subjects |
| GSK2254233A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any malaise | 6 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any gastrointestinal | 6 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any pain | 16 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any redness | 7 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any swelling | 7 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any fatigue | 13 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any headache | 10 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any malaise | 7 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any myalgia | 8 Subjects |
| GSK2254232A Group | Number of Subjects With Any Solicited Local and General Symptoms | Any temperature | 7 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any swelling | 0 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any pain | 4 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any malaise | 2 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any redness | 1 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any temperature | 2 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any gastrointestinal | 1 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any fatigue | 5 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any myalgia | 3 Subjects |
| Engerix Group | Number of Subjects With Any Solicited Local and General Symptoms | Any headache | 5 Subjects |
Primary
Number of Subjects With Any Unsolicited Adverse Events (AE)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time frame: During a 30-day (Days 0-29) follow up period after any vaccination
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2254233A Group | Number of Subjects With Any Unsolicited Adverse Events (AE) | 10 Subjects |
| GSK2254232A Group | Number of Subjects With Any Unsolicited Adverse Events (AE) | 10 Subjects |
| Engerix Group | Number of Subjects With Any Unsolicited Adverse Events (AE) | 6 Subjects |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.
Time frame: Days 0, 30, 60, 90, 180 and 420.
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 180 [N=14,17,7] | 1351.9 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 30 [N=15,17,7] | 1314.4 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 60 [N=15,17,7] | 791.3 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 90 [N=15,17,7] | 2142.2 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 0 [N=15,17,7] | 128.4 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 420 [N=13,16,6] | 943.4 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 0 [N=15,17,7] | 21128.2 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 30 [N=15,17,7] | 78690.3 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 60 [N=15,17,7] | 87193.5 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 90 [N=15,17,7] | 140774.7 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 180 [N=14,17,7] | 87320.6 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 420 [N=13,16,7] | 52951.7 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 0 [N=15,17,7] | 14298.4 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 30 [N=15,17,7] | 170818.2 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 60 [N=15,17,7] | 161893.6 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 90 [N=15,17,7] | 274366.3 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 180 [N=14,17,7] | 139883.3 LU/mL |
| GSK2254233A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 420 [N=13,16,7] | 92790.4 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 420 [N=13,16,7] | 59059.5 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 0 [N=15,17,7] | 92.3 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 90 [N=15,17,7] | 110714.0 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 0 [N=15,17,7] | 14059.5 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 30 [N=15,17,7] | 611.8 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 60 [N=15,17,7] | 87557.0 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 90 [N=15,17,7] | 163653.4 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 60 [N=15,17,7] | 322.6 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 180 [N=14,17,7] | 73013.5 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 180 [N=14,17,7] | 91157.5 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 90 [N=15,17,7] | 940.9 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 60 [N=15,17,7] | 58419.9 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 30 [N=15,17,7] | 106387.7 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 180 [N=14,17,7] | 416.2 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 30 [N=15,17,7] | 56628.0 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 420 [N=13,16,7] | 52798.1 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 420 [N=13,16,6] | 278.9 LU/mL |
| GSK2254232A Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 0 [N=15,17,7] | 23633.0 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 420 [N=13,16,6] | 230.4 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 0 [N=15,17,7] | 18313.4 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 30 [N=15,17,7] | 17881.4 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 60 [N=15,17,7] | 18387.8 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 60 [N=15,17,7] | 16396.0 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 420 [N=13,16,7] | 15832.6 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 90 [N=15,17,7] | 20184.0 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 180 [N=14,17,7] | 14537.6 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 90 [N=15,17,7] | 21144.8 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PhtD, Day 420 [N=13,16,7] | 14432.0 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 0 [N=15,17,7] | 286.9 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 30 [N=15,17,7] | 274.9 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 0 [N=15,17,7] | 17523.6 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 60 [N=15,17,7] | 242.9 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 90 [N=15,17,7] | 271.2 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-PD, Day 180 [N=14,17,7] | 242.8 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 30 [N=15,17,7] | 20190.6 LU/mL |
| Engerix Group | Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD) | Anti-Ply, Day 180 [N=14,17,7] | 16737.4 LU/mL |
Secondary
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations: Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17.
Time frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 480 [N=11,17,6] | 6.9 T-cells/million cells | Standard Deviation 183.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 480 [N=11,17,6] | 14.9 T-cells/million cells | Standard Deviation 33.8 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 74 [N=12,17,7] | 256.3 T-cells/million cells | Standard Deviation 137.3 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 74 [N=13,17,7] | -4.9 T-cells/million cells | Standard Deviation 335.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 0 [N=14,17,7] | 24.6 T-cells/million cells | Standard Deviation 287.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 480 [N=11,17,6] | 7.6 T-cells/million cells | Standard Deviation 44.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 14 [N=13,17,6] | -2.4 T-cells/million cells | Standard Deviation 236.8 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 14 [N=13,17,6] | -46.1 T-cells/million cells | Standard Deviation 350.3 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 480 [N=11,17,6] | 8.0 T-cells/million cells | Standard Deviation 38.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 0 [N=14,17,7] | -76.3 T-cells/million cells | Standard Deviation 212.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 74 [N=13,17,7] | -56.1 T-cells/million cells | Standard Deviation 183 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 480 [N=11,17,6] | 1.1 T-cells/million cells | Standard Deviation 141.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 0 [N=14,17,7] | 13.4 T-cells/million cells | Standard Deviation 32.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 480 [N=11,17,6] | 14.9 T-cells/million cells | Standard Deviation 139.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 0 [N=14,17,7] | -82.4 T-cells/million cells | Standard Deviation 212.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 14 [N=13,17,6] | -72.7 T-cells/million cells | Standard Deviation 373.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 74 [N=12,17,7] | 360.8 T-cells/million cells | Standard Deviation 267.3 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 74 [N=13,17,7] | -100.8 T-cells/million cells | Standard Deviation 245 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 0 [N=12,17,7] | 23.4 T-cells/million cells | Standard Deviation 76.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 14 [N=13,17,6] | 177.5 T-cells/million cells | Standard Deviation 263.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 0 [N=14,17,7] | 0.0 T-cells/million cells | Standard Deviation 30.8 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 480 [N=11,17,6] | 13.5 T-cells/million cells | Standard Deviation 34.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 74 [N=13,17,7] | 552.3 T-cells/million cells | Standard Deviation 374 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 14 [N=12,17,6] | 141.1 T-cells/million cells | Standard Deviation 90.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 14 [N=12,17,6] | 70.5 T-cells/million cells | Standard Deviation 94.3 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 480 [N=11,17,6] | 34.0 T-cells/million cells | Standard Deviation 65.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 14 [N=13,17,6] | 22.2 T-cells/million cells | Standard Deviation 42.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 74 [N=12,17,7] | 31.1 T-cells/million cells | Standard Deviation 65.2 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 0 [N=14,17,7] | 75.9 T-cells/million cells | Standard Deviation 63.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 480 [N=11,17,6] | 6.9 T-cells/million cells | Standard Deviation 30.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 14 [N=12,17,6] | 19.5 T-cells/million cells | Standard Deviation 58.6 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 14 [N=13,17,6] | 233.1 T-cells/million cells | Standard Deviation 199 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 0 [N=12,17,7] | 80.3 T-cells/million cells | Standard Deviation 83 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 0 [N=12,17,7] | 24.7 T-cells/million cells | Standard Deviation 80.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 74 [N=13,17,7] | 576.1 T-cells/million cells | Standard Deviation 348.2 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 74 [N=13,17,7] | 157.6 T-cells/million cells | Standard Deviation 239.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 480 [N=11,17,6] | 16.8 T-cells/million cells | Standard Deviation 37.4 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 0 [N=14,17,7] | -2.4 T-cells/million cells | Standard Deviation 21.4 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 0 [N=14,17,7] | -15.6 T-cells/million cells | Standard Deviation 305.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 0 [N=14,17,7] | 6.8 T-cells/million cells | Standard Deviation 23.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 14 [N=13,17,6] | 7.7 T-cells/million cells | Standard Deviation 35.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 74 [N=13,17,7] | 37.9 T-cells/million cells | Standard Deviation 39.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 480 [N=11,17,6] | -5.8 T-cells/million cells | Standard Deviation 23 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 14 [N=13,17,6] | 61.6 T-cells/million cells | Standard Deviation 122.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 74 [N=13,17,7] | 305.4 T-cells/million cells | Standard Deviation 294.4 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 74 [N=13,17,7] | -42.0 T-cells/million cells | Standard Deviation 265.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 0 [N=14,17,7] | 27.0 T-cells/million cells | Standard Deviation 52.6 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 14 [N=13,17,6] | 99.3 T-cells/million cells | Standard Deviation 163.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 74 [N=13,17,7] | 214.8 T-cells/million cells | Standard Deviation 235.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 480 [N=11,17,6] | 0.8 T-cells/million cells | Standard Deviation 22.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 0 [N=14,17,7] | -35.4 T-cells/million cells | Standard Deviation 328.2 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 14 [N=13,17,6] | 40.0 T-cells/million cells | Standard Deviation 120.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 480 [N=11,17,6] | 13.2 T-cells/million cells | Standard Deviation 176.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 14 [N=13,17,6] | -47.0 T-cells/million cells | Standard Deviation 242.2 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 74 [N=13,17,7] | -100.9 T-cells/million cells | Standard Deviation 252.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 480 [N=11,17,6] | -8.9 T-cells/million cells | Standard Deviation 103 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 0 [N=14,17,7] | -31.2 T-cells/million cells | Standard Deviation 236.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 14 [N=13,17,6] | -11.5 T-cells/million cells | Standard Deviation 128.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 74 [N=13,17,7] | -15.7 T-cells/million cells | Standard Deviation 150.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 480 [N=11,17,6] | -14.7 T-cells/million cells | Standard Deviation 146.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 0 [N=12,17,7] | 17.5 T-cells/million cells | Standard Deviation 39.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 14 [N=12,17,6] | -4.8 T-cells/million cells | Standard Deviation 42.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 74 [N=12,17,7] | 16.2 T-cells/million cells | Standard Deviation 66.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 480 [N=11,17,6] | -4.6 T-cells/million cells | Standard Deviation 18.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 0 [N=12,17,7] | 29.5 T-cells/million cells | Standard Deviation 56.4 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 14 [N=12,17,6] | 26.1 T-cells/million cells | Standard Deviation 52.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 74 [N=12,17,7] | 114.1 T-cells/million cells | Standard Deviation 112.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 480 [N=11,17,6] | -0.5 T-cells/million cells | Standard Deviation 28.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 0 [N=12,17,7] | 63.9 T-cells/million cells | Standard Deviation 79.4 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 14 [N=12,17,6] | 95.4 T-cells/million cells | Standard Deviation 88.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 74 [N=12,17,7] | 169.9 T-cells/million cells | Standard Deviation 125.6 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 480 [N=11,17,6] | 14.0 T-cells/million cells | Standard Deviation 26.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 14 [N=13,17,6] | 92.5 T-cells/million cells | Standard Deviation 138.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 14 [N=13,17,6] | 7.2 T-cells/million cells | Standard Deviation 29 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 0 [N=12,17,7] | 8.0 T-cells/million cells | Standard Deviation 23 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 0 [N=14,17,7] | 133.4 T-cells/million cells | Standard Deviation 209.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 74 [N=12,17,7] | 82.3 T-cells/million cells | Standard Deviation 83 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 14 [N=12,17,6] | -5.5 T-cells/million cells | Standard Deviation 71 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 480 [N=11,17,6] | 14.5 T-cells/million cells | Standard Deviation 25.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 0 [N=12,17,7] | 122.1 T-cells/million cells | Standard Deviation 158.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 74 [N=13,17,7] | -1.9 T-cells/million cells | Standard Deviation 34.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 74 [N=12,17,7] | -17.0 T-cells/million cells | Standard Deviation 52.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 14 [N=13,17,6] | 6.3 T-cells/million cells | Standard Deviation 20.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 0 [N=14,17,7] | 10.4 T-cells/million cells | Standard Deviation 21.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PD specific, Day 480 [N=11,17,6] | 7.3 T-cells/million cells | Standard Deviation 15.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PhtD specific, Day 0 [N=14,17,7] | -5.1 T-cells/million cells | Standard Deviation 16.6 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 74 [N=13,17,7] | -43.6 T-cells/million cells | Standard Deviation 242.6 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 0 [N=12,17,7] | 12.4 T-cells/million cells | Standard Deviation 41.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 14 [N=12,17,6] | 88.7 T-cells/million cells | Standard Deviation 57.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 14 [N=12,17,6] | 2.4 T-cells/million cells | Standard Deviation 49.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 14 [N=13,17,6] | 339.8 T-cells/million cells | Standard Deviation 1056.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 480 [N=11,17,6] | 58.7 T-cells/million cells | Standard Deviation 94.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 74 [N=13,17,7] | -125.6 T-cells/million cells | Standard Deviation 453.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 480 [N=11,17,6] | 161.0 T-cells/million cells | Standard Deviation 394.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 0 [N=14,17,7] | 238.1 T-cells/million cells | Standard Deviation 1001.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PhtD specific, Day 480 [N=11,17,6] | 196.2 T-cells/million cells | Standard Deviation 351.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 14 [N=13,17,6] | 381.5 T-cells/million cells | Standard Deviation 1016.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 74 [N=12,17,7] | -10.1 T-cells/million cells | Standard Deviation 45.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 0 [N=14,17,7] | 256.0 T-cells/million cells | Standard Deviation 1009.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, PD specific, Day 0 [N=14,17,7] | 267.3 T-cells/million cells | Standard Deviation 887.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, PD specific, Day 74 [N=13,17,7] | -6.0 T-cells/million cells | Standard Deviation 32.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 14 [N=13,17,6] | 407.2 T-cells/million cells | Standard Deviation 1227.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 480 [N=11,17,6] | 8.5 T-cells/million cells | Standard Deviation 13.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, dPly specific, Day 480 [N=11,17,6] | 10.2 T-cells/million cells | Standard Deviation 19.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 74 [N=13,17,7] | -126.9 T-cells/million cells | Standard Deviation 271.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 1, dPly specific, Day 74 [N=13,17,7] | 76.7 T-cells/million cells | Standard Deviation 90.6 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 17, PhtD specific, Day 480 [N=11,17,6] | 9.8 T-cells/million cells | Standard Deviation 20.2 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | Th 2, dPly specific, Day 480 [N=11,17,6] | 195.0 T-cells/million cells | Standard Deviation 414.8 |
Secondary
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations: C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17).
Time frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 0 [N=14,17,7] | -65.0 T-cells/million cells | Standard Deviation 166.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 480 [N=11,17,6] | -18.9 T-cells/million cells | Standard Deviation 91.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 0 [N=14,17,7] | -25.2 T-cells/million cells | Standard Deviation 188.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 14 [N=12,17,6] | -4.6 T-cells/million cells | Standard Deviation 54 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 74 [N=12,17,7] | 19.0 T-cells/million cells | Standard Deviation 69.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 14 [N=13,17,6] | 5.0 T-cells/million cells | Standard Deviation 267.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 74 [N=13,17,7] | -133.3 T-cells/million cells | Standard Deviation 225.1 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 14 [N=12,17,6] | 81.8 T-cells/million cells | Standard Deviation 105.4 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 74 [N=13,17,7] | -29.8 T-cells/million cells | Standard Deviation 253.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 480 [N=11,17,6] | -3.7 T-cells/million cells | Standard Deviation 150.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 0 [N=12,17,7] | -19.0 T-cells/million cells | Standard Deviation 150.8 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 480 [N=11,17,6] | -219.1 T-cells/million cells | Standard Deviation 655 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 0 [N=12,17,7] | -45.8 T-cells/million cells | Standard Deviation 119.5 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 480 [N=11,17,6] | -9.5 T-cells/million cells | Standard Deviation 525.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 74 [N=12,17,7] | 7.3 T-cells/million cells | Standard Deviation 74 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 480 [N=11,17,6] | 7.9 T-cells/million cells | Standard Deviation 60 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 74 [N=12,17,7] | 134.3 T-cells/million cells | Standard Deviation 321.7 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 14 [N=13,17,6] | -53.2 T-cells/million cells | Standard Deviation 277 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 0 [N=14,17,7] | 36.8 T-cells/million cells | Standard Deviation 276.2 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 14 [N=12,17,6] | 28.8 T-cells/million cells | Standard Deviation 121.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 74 [N=13,17,7] | -41.2 T-cells/million cells | Standard Deviation 269.3 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 14 [N=13,17,6] | -164.8 T-cells/million cells | Standard Deviation 247.9 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 0 [N=12,17,7] | -30.4 T-cells/million cells | Standard Deviation 144.8 |
| GSK2254233A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 480 [N=11,17,6] | 4.6 T-cells/million cells | Standard Deviation 517.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 14 [N=13,17,6] | 52.9 T-cells/million cells | Standard Deviation 170.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 0 [N=14,17,7] | 53.5 T-cells/million cells | Standard Deviation 154.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 480 [N=11,17,6] | 37.8 T-cells/million cells | Standard Deviation 233.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 0 [N=14,17,7] | 28.0 T-cells/million cells | Standard Deviation 115.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 14 [N=13,17,6] | -20.7 T-cells/million cells | Standard Deviation 109.2 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 74 [N=13,17,7] | 7.9 T-cells/million cells | Standard Deviation 238.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 480 [N=11,17,6] | 68.1 T-cells/million cells | Standard Deviation 373.3 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 74 [N=13,17,7] | 122.5 T-cells/million cells | Standard Deviation 244.6 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 480 [N=11,17,6] | 105.6 T-cells/million cells | Standard Deviation 216.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 0 [N=14,17,7] | 15.3 T-cells/million cells | Standard Deviation 129.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 14 [N=13,17,6] | -29.8 T-cells/million cells | Standard Deviation 208.2 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 74 [N=13,17,7] | 41.6 T-cells/million cells | Standard Deviation 226.5 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 480 [N=11,17,6] | 58.1 T-cells/million cells | Standard Deviation 230.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 0 [N=12,17,7] | 74.5 T-cells/million cells | Standard Deviation 195.7 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 14 [N=12,17,6] | 8.2 T-cells/million cells | Standard Deviation 98.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 74 [N=12,17,7] | -11.9 T-cells/million cells | Standard Deviation 149 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 480 [N=11,17,6] | 103.5 T-cells/million cells | Standard Deviation 236.9 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 0 [N=12,17,7] | 56.0 T-cells/million cells | Standard Deviation 160.6 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 14 [N=12,17,6] | 58.8 T-cells/million cells | Standard Deviation 130.8 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 74 [N=12,17,7] | 20.5 T-cells/million cells | Standard Deviation 118.6 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 0 [N=12,17,7] | 31.0 T-cells/million cells | Standard Deviation 110 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 14 [N=12,17,6] | 66.2 T-cells/million cells | Standard Deviation 124.1 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 74 [N=12,17,7] | -30.5 T-cells/million cells | Standard Deviation 82.2 |
| GSK2254232A Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 480 [N=11,17,6] | 38.7 T-cells/million cells | Standard Deviation 174.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 480 [N=11,17,6] | 109.8 T-cells/million cells | Standard Deviation 210.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 480 [N=11,17,6] | 78.0 T-cells/million cells | Standard Deviation 110.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 74 [N=13,17,7] | -7.4 T-cells/million cells | Standard Deviation 229.8 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 14 [N=12,17,6] | 1.9 T-cells/million cells | Standard Deviation 145.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 0 [N=12,17,7] | 64.7 T-cells/million cells | Standard Deviation 106.9 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 14 [N=13,17,6] | -54.3 T-cells/million cells | Standard Deviation 190.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 0 [N=14,17,7] | 3.3 T-cells/million cells | Standard Deviation 218.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 14 [N=12,17,6] | 15.7 T-cells/million cells | Standard Deviation 146.4 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 0 [N=14,17,7] | 68.6 T-cells/million cells | Standard Deviation 271 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 480 [N=11,17,6] | 50.3 T-cells/million cells | Standard Deviation 66.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PhtD specific, Day 74 [N=12,17,7] | 11.3 T-cells/million cells | Standard Deviation 68.2 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 480 [N=11,17,6] | 32.7 T-cells/million cells | Standard Deviation 77.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 74 [N=13,17,7] | -67.1 T-cells/million cells | Standard Deviation 162.7 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 480 [N=11,17,6] | -15.2 T-cells/million cells | Standard Deviation 114.2 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 74 [N=13,17,7] | -88.1 T-cells/million cells | Standard Deviation 182.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 74 [N=12,17,7] | -17.1 T-cells/million cells | Standard Deviation 62.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 0 [N=12,17,7] | 38.7 T-cells/million cells | Standard Deviation 79.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 14 [N=13,17,6] | -104.0 T-cells/million cells | Standard Deviation 220.2 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, dPly specific, Day 0 [N=12,17,7] | 15.6 T-cells/million cells | Standard Deviation 83.3 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 14 [N=12,17,6] | -35.2 T-cells/million cells | Standard Deviation 77.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, dPly specific, Day 0 [N=14,17,7] | -14.0 T-cells/million cells | Standard Deviation 192.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PD specific, Day 14 [N=13,17,6] | -44.3 T-cells/million cells | Standard Deviation 224.5 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C2, PD specific, Day 74 [N=12,17,7] | 21.9 T-cells/million cells | Standard Deviation 81.1 |
| Engerix Group | Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | C1, PhtD specific, Day 480 [N=11,17,6] | 84.7 T-cells/million cells | Standard Deviation 114.5 |