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This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New generation influenza vaccine GSK2186877A Group | Experimental | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
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| Fluarix elderly Group | Active Comparator | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 |
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| Fluarix young Group | Active Comparator | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' influenza vaccine GSK2186877A | Biological | One intramuscular injection at Day 0 |
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| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers | The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ) | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. | At Day 0, 21, 42 and 180 |
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Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
Elderly adults:
• A man or woman 65 year of age or older at the time of the first vaccination.
Young adults:
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 | Houston | Texas | 77030 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25078387 | Derived | Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112147 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
| FG001 | Fluarix Elderly Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| GSK Biologicals' Fluarix | Biological | One intramuscular injection at Day 0 |
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| The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. | At Day 0, 21, 42 and 180 |
| Haemagglutinin Inhibition (HI) Antibody Titers | Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains. | At Day 0, 21, 42 and 180 |
| The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. | Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10 | At Day 0, 21, 42 and 180 |
| The Number of Subjects Seroconverted to HI Antibodies | Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 21, 42 and 180 |
| HI Antibody Seroconversion Factors | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. | At Day 21, 42 and 180 |
| The Number of Subjects Seroprotected to HI Antibodies | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | At Day 0, 21, 42 and 180 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity. | Day 0 -6 |
| Duration of Solicited Local AEs | Duration was defined as the number of days with any grade of local symptoms. | Day 0 -6 |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination. | Day 0 -6 |
| Duration of Solicited General AEs | Duration was defined as number of days with any grade of general symptoms. | Day 0 -6 |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. | Day 0-20 |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. | Day 0-179 |
| Number of Subjects Reporting Any AEs of Specific Interest (AESI) | AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination. | Day 0-364 |
| Number of Subjects Reporting Any and Related 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 or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination. | Day 0-364 |
| Barcelona |
| 08035 |
| Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Marid | 28040 | Spain |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112147 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112147 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112147 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112147 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112147 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
| FG002 | Fluarix Young Group | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
| BG001 | Fluarix Elderly Group | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 |
| BG002 | Fluarix Young Group | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers | The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ) | Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group. | Posted | Geometric Mean | Standard Deviation | cells per million CD4+ Tcells | Day 21 |
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| Secondary | The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. | Posted | Geometric Mean | Standard Deviation | cells per million CD4+ Tcells | At Day 0, 21, 42 and 180 |
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| Secondary | The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. | The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Geometric Mean | Standard Deviation | cells per million CD4+ Tcells | At Day 0, 21, 42 and 180 |
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| Secondary | Haemagglutinin Inhibition (HI) Antibody Titers | Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains. | The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 0, 21, 42 and 180 |
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| Secondary | The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. | Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10 | The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Count of Participants | Participants | At Day 0, 21, 42 and 180 |
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| Secondary | The Number of Subjects Seroconverted to HI Antibodies | Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Count of Participants | Participants | At Day 21, 42 and 180 |
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| Secondary | HI Antibody Seroconversion Factors | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. | The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | At Day 21, 42 and 180 |
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| Secondary | The Number of Subjects Seroprotected to HI Antibodies | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. | Posted | Count of Participants | Participants | At Day 0, 21, 42 and 180 |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0 -6 |
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| Secondary | Duration of Solicited Local AEs | Duration was defined as the number of days with any grade of local symptoms. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom. | Posted | Median | Full Range | Days | Day 0 -6 |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0 -6 |
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| Secondary | Duration of Solicited General AEs | Duration was defined as number of days with any grade of general symptoms. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom. | Posted | Median | Full Range | Days | Day 0 -6 |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0-20 |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0-179 |
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| Secondary | Number of Subjects Reporting Any AEs of Specific Interest (AESI) | AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0-364 |
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| Secondary | Number of Subjects Reporting Any and Related 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 or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Day 0-364 |
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Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
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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 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | 5 | 69 | 53 | 69 | ||
| EG001 | Fluarix Elderly Group | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | 11 | 73 | 27 | 73 | ||
| EG002 | Fluarix Young Group | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 | 1 | 50 | 43 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | Non-systematic Assessment |
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| Amnesia | Nervous system disorders | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Nephritis | Renal and urinary disorders | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Urinary tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Arthralgia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Myalgia | General disorders | Systematic Assessment |
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| Shivering | General disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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