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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.
This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2254233A Group | Experimental | Subjects received 2 doses of 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. |
|
| GSK2254232A Group | Experimental | Subjects received 2 doses of non-adjuvanted 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. |
|
| Engerix Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2231395A | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During a 7-day follow up period after any vaccination |
| 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. | During a 30-day (Days 0-29) follow up period after any vaccination |
| 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. | From Day 0 to Day 420 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 0, 30, 60, 90, 180 and 420. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Karlskrona | SE-371 41 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24173029 | Derived | Berglund J, Vink P, Tavares Da Silva F, Lestrate P, Boutriau D. Safety, immunogenicity, and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults. Clin Vaccine Immunol. 2014 Jan;21(1):56-65. doi: 10.1128/CVI.00430-13. Epub 2013 Oct 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2254233A Group | Subjects received 2 doses of 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. |
| FG001 | GSK2254232A Group | Subjects received 2 doses of non-adjuvanted 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | GSK2254232A Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During a 7-day follow up period after any vaccination |
|
Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2254233A Group | Subjects received 2 doses of 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C075654 | Engerix-B |
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| Engerix-B | Biological | Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. |
|
| During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420 |
| 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. | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. |
| 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. | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. |
| 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. | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. |
| 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). | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | GSK2254232A Group | Subjects received 2 doses of non-adjuvanted 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. |
| OG002 | 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. |
|
|
| 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. | The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During a 30-day (Days 0-29) follow up period after any vaccination |
|
|
|
| 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. | The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | From Day 0 to Day 420 |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420 |
|
|
|
| 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. | The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. |
|
|
|
| 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. | The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | LU/mL | Days 0, 30, 60, 90, 180 and 420. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | T-cells/million cells | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | T-cells/million cells | Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. |
|
|
|
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | GSK2254232A Group | Subjects received 2 doses of non-adjuvanted 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. | 0 | 17 | 17 | 17 |
| EG002 | 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. | 0 | 8 | 8 | 8 |
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Feeling hot | General disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Injection site reaction | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsilitis | Infections and infestations | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
|
| ALT, Post Dose 1 (Day 60) [N=15,17,7] |
|
| ALT, Post Dose 2 (Day 67) [N=15,17,7] |
|
| ALT, Post Dose 2 (Day 180) [N=14,17,7] |
|
| ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6] |
|
| ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| AST, Pre Dose 1 (Day 0) [N=2,3,0] |
|
| AST, Post Dose 1 (Day 7) [N=15,17,8] |
|
| AST, Post Dose 1 (Day 60) [N=15,17,7] |
|
| AST, Post Dose 2 (Day 67) [N=15,17,7] |
|
| AST, Post Dose 2 (Day 180) [N=15,17,7] |
|
| AST, Post Dose 2 or 3 (Day 300) [N=15,16,6] |
|
| AST, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| CREA, Pre Dose 1 (Day 0) [N=2,3,0] |
|
| CREA, Post Dose 1 (Day 7) [N=15,17,8] |
|
| CREA, Post Dose 1 (Day 60) [N=15,17,7] |
|
| CREA, Post Dose 2 (Day 67) [N=15,17,7] |
|
| CREA, Post Dose 2 (Day 180) [N=15,17,7] |
|
| CREA, Post Dose 2 or 3 (Day 300) [N=15,16,5] |
|
| CREA, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| URE, Pre Dose 1 (Day 0) [N=2,3,0] |
|
| URE, Post Dose 1 (Day 7) [N=15,17,8] |
|
| URE, Post Dose 1 (Day 60) [N=15,17,7] |
|
| URE, Post Dose 2 (Day 67) [N=15,17,7] |
|
| URE, Post Dose 2 (Day 180) [N=15,17,7] |
|
| URE, Post Dose 2 or 3 (Day 300) [N=15,16,5] |
|
| URE, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
|
| RBC, Post Dose 1 (Day 60) [N=15,17,7] |
|
| RBC, Post Dose 2 (Day 67) [N=15,17,7] |
|
| RBC, Post Dose 2 (Day 180) [N=15,17,7] |
|
| RBC, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| RBC, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| WBC High, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| WBC High, Post Dose 1 (Day 7) [N=15,17,8] |
|
| WBC High, Post Dose 1 (Day 60) [N=15,17,7] |
|
| WBC High, Post Dose 2 (Day 67) [N=15,17,7] |
|
| WBC High, Post Dose 2 (Day 180) [N=15,17,7] |
|
| WBC High, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| WBC High, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| WBC Low, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| WBC Low, Post Dose 1 (Day 7) [N=15,17,8] |
|
| WBC Low, Post Dose 1 (Day 60) [N=15,17,7] |
|
| WBC Low, Post Dose 2 (Day 67) [N=15,17,7] |
|
| WBC Low, Post Dose 2 (Day 180) [N=15,17,7] |
|
| WBC Low, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| WBC Low, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| PLA, Pre Dose 1 (Day 0) [N=2,3,0] |
|
| PLA, Pre Dose 1 (Day 7) [N=15,17,8] |
|
| PLA, Post Dose 1 (Day 60) [N=15,17,7] |
|
| PLA, Post Dose 2 (Day 67) [N=15,17,7] |
|
| PLA, Post Dose 2 (Day 180) [N=15,17,7] |
|
| PLA, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| PLA, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| HEM, Pre Dose 1 (Day 0) [N=2,3,0] |
|
| HEM, Post Dose 1 (Day 7) [N=15,17,8] |
|
| HEM, Post Dose 1 (Day 60) [N=15,17,7] |
|
| HEM, Post Dose 2 (Day 67) [N=15,17,7] |
|
| HEM, Post Dose 2 (Day 180) [N=15,17,7] |
|
| HEM, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| HEM, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
|
| BAS, Post Dose 1 (Day 60) [N=15,17,7] |
|
| BAS, Post Dose 2 (Day 67) [N=15,17,7] |
|
| BAS, Post Dose 2 (Day 180) [N=15,17,7] |
|
| BAS, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| BAS, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| NEU, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| NEU, Post Dose 1 (Day 7) [N=15,17,8] |
|
| NEU, Post Dose 1 (Day 60) [N=15,17,7] |
|
| NEU, Post Dose 2 (Day 67) [N=15,17,7] |
|
| NEU, Post Dose 2 (Day 180) [N=15,17,7] |
|
| NEU, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| NEU, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| LYM, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| LYM, Post Dose 1 (Day 7) [N=15,17,8] |
|
| LYM, Post Dose 1 (Day 60) [N=15,17,7] |
|
| LYM, Post Dose 2 (Day 67) [N=15,17,7] |
|
| LYM, Post Dose 2 (Day 180) [N=15,17,7] |
|
| LYM, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| LYM, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| EOS, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| EOS, Post Dose 1 (Day 7) [N=15,17,8] |
|
| EOS, Post Dose 1 (Day 60) [N=15,17,7] |
|
| EOS, Post Dose 2 (Day 67) [N=15,17,7] |
|
| EOS, Post Dose 2 (Day 180) [N=15,17,7] |
|
| EOS, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| EOS, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| MON, Pre Dose 1 (Day 0) [N=2,4,0] |
|
| MON, Post Dose 1 (Day 7) [N=15,17,8] |
|
| MON, Post Dose 1 (Day 60) [N=15,17,7] |
|
| MON, Post Dose 2 (Day 67) [N=15,17,7] |
|
| MON, Post Dose 2 (Day 180) [N=15,17,7] |
|
| MON, Post Dose 2 or 3 (Day 300) [N=15,16,7] |
|
| MON, Post Dose 2 or 3 (Day 420) [N=14,16,7] |
|
| Anti-PD, Day 30 [N=15,17,7] |
|
| Anti-PD, Day 60 [N=15,17,7] |
|
| Anti-PD, Day 90 [N=15,17,7] |
|
| Anti-PD, Day 180 [N=14,17,7] |
|
| Anti-PD, Day 420 [N=13,16,6] |
|
| Anti-PhtD, Day 0 [N=15,17,7] |
|
| Anti-PhtD, Day 30 [N=15,17,7] |
|
| Anti-PhtD, Day 60 [N=15,17,7] |
|
| Anti-PhtD, Day 90 [N=15,17,7] |
|
| Anti-PhtD, Day 180 [N=14,17,7] |
|
| Anti-PhtD, Day 420 [N=13,16,7] |
|
| Anti-Ply, Day 0 [N=15,17,7] |
|
| Anti-Ply, Day 30 [N=15,17,7] |
|
| Anti-Ply, Day 60 [N=15,17,7] |
|
| Anti-Ply, Day 90 [N=15,17,7] |
|
| Anti-Ply, Day 180 [N=14,17,7] |
|
| Anti-Ply, Day 420 [N=13,16,7] |
|
|
| Th 1, PD specific, Day 74 [N=13,17,7] |
|
| Th 1, PD specific, Day 480 [N=11,17,6] |
|
| Th 1, PhtD specific, Day 0 [N=14,17,7] |
|
| Th 1, PhtD specific, Day 14 [N=13,17,6] |
|
| Th 1, PhtD specific, Day 74 [N=13,17,7] |
|
| Th 1, PhtD specific, Day 480 [N=11,17,6] |
|
| Th 1, dPly specific, Day 0 [N=14,17,7] |
|
| Th 1, dPly specific, Day 14 [N=13,17,6] |
|
| Th 1, dPly specific, Day 74 [N=13,17,7] |
|
| Th 1, dPly specific, Day 480 [N=11,17,6] |
|
| Th 2, PD specific, Day 0 [N=14,17,7] |
|
| Th 2, PD specific, Day 14 [N=13,17,6] |
|
| Th 2, PD specific, Day 74 [N=13,17,7] |
|
| Th 2, PD specific, Day 480 [N=11,17,6] |
|
| Th 2, PhtD specific, Day 0 [N=14,17,7] |
|
| Th 2, PhtD specific, Day 14 [N=13,17,6] |
|
| Th 2, PhtD specific, Day 74 [N=13,17,7] |
|
| Th 2, PhtD specific, Day 480 [N=11,17,6] |
|
| Th 2, dPly specific, Day 0 [N=14,17,7] |
|
| Th 2, dPly specific, Day 14 [N=13,17,6] |
|
| Th 2, dPly specific, Day 74 [N=13,17,7] |
|
| Th 2, dPly specific, Day 480 [N=11,17,6] |
|
| Th 17, PD specific, Day 0 [N=12,17,7] |
|
| Th 17, PD specific, Day 14 [N=12,17,6] |
|
| Th 17, PD specific, Day 74 [N=12,17,7] |
|
| Th 17, PD specific, Day 480 [N=11,17,6] |
|
| Th 17, PhtD specific, Day 0 [N=12,17,7] |
|
| Th 17, PhtD specific, Day 14 [N=12,17,6] |
|
| Th 17, PhtD specific, Day 74 [N=12,17,7] |
|
| Th 17, PhtD specific, Day 480 [N=11,17,6] |
|
| Th 17, dPly specific, Day 0 [N=12,17,7] |
|
| Th 17, dPly specific, Day 14 [N=12,17,6] |
|
| Th 17, dPly specific, Day 74 [N=12,17,7] |
|
| Th 17, dPly specific, Day 480 [N=11,17,6] |
|
|
| C1, PD specific, Day 74 [N=13,17,7] |
|
| C1, PD specific, Day 480 [N=11,17,6] |
|
| C1, PhtD specific, Day 0 [N=14,17,7] |
|
| C1, PhtD specific, Day 14 [N=13,17,6] |
|
| C1, PhtD specific, Day 74 [N=13,17,7] |
|
| C1, PhtD specific, Day 480 [N=11,17,6] |
|
| C1, dPly specific, Day 0 [N=14,17,7] |
|
| C1, dPly specific, Day 14 [N=13,17,6] |
|
| C1, dPly specific, Day 74 [N=13,17,7] |
|
| C1, dPly specific, Day 480 [N=11,17,6] |
|
| C2, PD specific, Day 0 [N=12,17,7] |
|
| C2, PD specific, Day 14 [N=12,17,6] |
|
| C2, PD specific, Day 74 [N=12,17,7] |
|
| C2, PD specific, Day 480 [N=11,17,6] |
|
| C2, PhtD specific, Day 0 [N=12,17,7] |
|
| C2, PhtD specific, Day 14 [N=12,17,6] |
|
| C2, PhtD specific, Day 74 [N=12,17,7] |
|
| C2, PhtD specific, Day 480 [N=11,17,6] |
|
| C2, dPly specific, Day 0 [N=12,17,7] |
|
| C2, dPly specific, Day 14 [N=12,17,6] |
|
| C2, dPly specific, Day 74 [N=12,17,7] |
|
| C2, dPly specific, Day 480 [N=11,17,6] |
|