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The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New generation influenza vaccine GSK2186877A Group | Experimental | Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A. |
|
| Fluarix elderly Group | Active Comparator | Subjects aged ≥66 years received one dose of Fluarix vaccine. |
|
| Fluarix young Group | Active Comparator | Subjects aged 19-43 years received one dose of Fluarix vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine GSK2186877A | Biological | One intramuscularly injection at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling. | Day 0-6 |
| Duration of Solicited Local AEs | Duration was defined as 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 oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms 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 grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. |
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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 | Clearwater | Florida | 33761 | United States | ||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 111738 | Individual Participant Data Set | 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 ≥66 years received one dose of New generation influenza vaccine GSK2186877A. |
| FG001 | Fluarix Elderly Group | Subjects aged ≥66 years received one dose of Fluarix vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK Biologicals' Fluarixâ„¢ | Biological | One intramuscularly injection at Day 0 |
|
| Day 0-20 |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. | Day 0-20 |
| Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | 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 grade. | Day 0-20 |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | 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 and related was an event assessed by the investigator as causally related to the study vaccination. | Day 0-20 |
| Day 21-179 |
| Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. | Day 21-364. |
| Haemagglutination Inhibition (HI) Antibody Titers | Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 0-21 |
| The Number of Subjects Seropositive to HI Antibodies | A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 0-21 |
| The Number of Subjects Seroprotected by HI Antibodies | A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 0-21 |
| The Number of Subjects Seroconverted to HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination 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 vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | At Day 21 |
| HI Antibody Seroconversion Factors (SCF) | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | At Day 21 |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | 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 and related was an event assessed by the investigator as causally related to the study vaccination. | Day 21-364 |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| GSK Investigational Site | Milford | Massachusetts | 01757 | United States |
| GSK Investigational Site | Chaska | Minnesota | 55318 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Poughkeepsie | New York | 12601 | United States |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Messkirch | Baden-Wurttemberg | 88605 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86150 | Germany |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Höhenkirchen-Siegertsbrunn | Bavaria | 85635 | Germany |
| GSK Investigational Site | Langquaid | Bavaria | 84085 | Germany |
| GSK Investigational Site | Rüdersdorf | Brandenburg | 15562 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04129 | Germany |
| GSK Investigational Site | Berlin | 10365 | Germany |
| GSK Investigational Site | Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | 12687 | Germany |
| GSK Investigational Site | Berlin | 13086 | Germany |
| GSK Investigational Site | Berlin | 13507 | Germany |
| GSK Investigational Site | Bekkestua | 1319 | Norway |
| GSK Investigational Site | Bergen | 5094 | Norway |
| GSK Investigational Site | Elverum | 2408 | Norway |
| GSK Investigational Site | Fredrikstad | N-1601 | Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Haugesund | 5528 | Norway |
| GSK Investigational Site | Skien | 3717 | Norway |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111738 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Fluarix Young Group | Subjects aged 19-43 years received one dose of Fluarix vaccine. |
| Completed at Day 21 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A. |
| BG001 | Fluarix Elderly Group | Subjects aged ≥66 years received one dose of Fluarix vaccine. |
| BG002 | Fluarix Young Group | Subjects aged 19-43 years received one dose of Fluarix vaccine. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| 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 | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed. | Posted | Count of Participants | Participants | Day 0-6 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Duration of Solicited Local AEs | Duration was defined as 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 and symptom sheet completed only on subjects that reported the specific symptom. | Posted | Median | Full Range | Days | Day 0-6 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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 oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms 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 and symptom sheet completed. | Posted | Count of Participants | Participants | Day 0-6 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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 and symptom sheet completed only on subjects that reported the specific symptom. | Posted | Median | Full Range | Days | Day 0-6 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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 grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event 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 0-20 |
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| Primary | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a 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 0-20 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | 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 grade. | 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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| Primary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | 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 and related was an event 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 0-20 |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a 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 21-179 |
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| Secondary | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a 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 21-364. |
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| Secondary | Haemagglutination Inhibition (HI) Antibody Titers | Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and 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 | 95% Confidence Interval | titer | Day 0-21 |
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| Secondary | The Number of Subjects Seropositive to HI Antibodies | A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and 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 | Count of Participants | Participants | Day 0-21 |
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| Secondary | The Number of Subjects Seroprotected by HI Antibodies | A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and 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 | Count of Participants | Participants | Day 0-21 |
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| Secondary | The Number of Subjects Seroconverted to HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination 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 vaccine strains included A/Brisbane, A/Uruguay and 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 | Count of Participants | Participants | At Day 21 |
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| Secondary | HI Antibody Seroconversion Factors (SCF) | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available. | Posted | Mean | 95% Confidence Interval | fold increase | At Day 21 |
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| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | 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 and related was an event 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 21-364 |
|
Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
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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 ≥66 years received one dose of New generation influenza vaccine GSK2186877A. | 40 | 375 | 218 | 375 | ||
| EG001 | Fluarix Elderly Group | Subjects aged ≥66 years received one dose of Fluarix vaccine. | 43 | 393 | 109 | 393 | ||
| EG002 | Fluarix Young Group | Subjects aged 19-43 years received one dose of Fluarix vaccine. | 4 | 203 | 133 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Peripheral arterial occlusive disease | Vascular disorders | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Urosepsis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 0 to Day 20 |
| |
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pyelonephritis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Urosepsis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Coronary artery occlusion | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pneumonia staphylococcal | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cerebral haemorrhage | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Diverticulitis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
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| Chest pain | General disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
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| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Fatigue | General disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Angina pectoris | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Arrhythmia | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
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| Adverse drug reaction | General disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Carotid artery stenosis | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Volvulus | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Death | General disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Bronchitis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cystocele | Reproductive system and breast disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Haemorrhagic stroke | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Left ventricular failure | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Lymphatic fistula | Vascular disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Wound infection | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Factor XIII deficiency | Congenital, familial and genetic disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Herpes zoster | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Arterial occlusive disease | Vascular disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Stress cardiomyopathy | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Aesthesioneuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Aortic aneurysm | Vascular disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Atrial flutter | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Sepsis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Peptic ulcer | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Chest discomfort | General disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Femoral arterial stenosis | Vascular disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Appendicitis | Infections and infestations | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Dizziness | Nervous system disorders | Non-systematic Assessment | SAE was assessed from Day 21-364 |
| |
| Gun shot wound | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE was assessed from Day 21-364 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Myalgia | General disorders | Systematic Assessment |
| ||
| Shivering | 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.
| 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 |
Not provided
Not provided
| Male |
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| Title | Measurements |
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| Any pain |
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| Grade 3 pain |
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| Grade 3 redness |
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| Any swelling |
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| Grade 3 swelling |
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