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A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarixâ„¢
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLUARIX 50-64 YEARS GROUP | Experimental | Adult subjects aged between and including 50-64 years who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
|
| FLUARIX 65+ YEARS GROUP | Experimental | Elderly subjects aged 65 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarixâ„¢ | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported. | From Month 0 to Month 6 |
| Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay. | From Month 0 to Month 6 |
| Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. | From Month 0 to Month 6 |
| Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. | From Month 0 to Month 6 |
| Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1). | From Month 0 to Month 6 |
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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 | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| 107564 | 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 | Fluarix 50-64 Years Group | Adult subjects aged between and including 50-64 years who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
| FG001 | Fluarix 65+ Years Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications |
ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation. |
| From Month 0 to Month 6 |
| Number of Subjects With Influenza-related Complications | ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode). | From Month 0 to Month 6 |
| Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | Death due to lab confirmed influenza infection was recorded during the influeza period only. | From Month 0 to Month 6 |
| Number of Subjects With Fatal Outcomes | Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza | From Month 0 to Month 6 |
| Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | RSV infection was determined by the RT-PCR assay. | From Month 0 to Month 6 |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or 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 and related was an event assessed by the investigator as causally related to the study vaccination. | From Month 0 to Month 6 |
| Number of Seroconverted Subjects for Each Influenza Strain | A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia. | At Day 21 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. | At Day 21 |
| Number of Seroprotected Subjects Against the 3 Influenza Strains | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40. | At Day 0 (PRE) |
| Number of Seroprotected Subjects Against the 3 Influenza Strains | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40. | At Day 21 |
| Number of Seropositive Subjects for Each Influenza Strain | A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10. | At Day 0 (PRE) |
| Number of Seropositive Subjects for Each Influenza Strain | A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10. | At Day 21 |
| Serum HI Antibody Titers for Each Influenza Strain | Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 0 (PRE) |
| Serum HI Antibody Titers for Each Influenza Strain | Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 21 |
| Delray Beach |
| Florida |
| 33484 |
| United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Camillus | New York | 13031 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Güglingen | Baden-Wurttemberg | 74363 | Germany |
| GSK Investigational Site | Rudersberg | Baden-Wurttemberg | 73635 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14469 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Rhaunen | Rhineland-Palatinate | 55624 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01067 | Germany |
| GSK Investigational Site | Leipzg | Saxony | 04109 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04229 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | 13359 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Hamburg | 22335 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Hamburg | 22525 | Germany |
| GSK Investigational Site | Utrecht | 3584 CX | Netherlands |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Krakow | 31-305 | Poland |
| GSK Investigational Site | Mielec | 39-300 | Poland |
| GSK Investigational Site | PorÄ…bka | Poland |
| GSK Investigational Site | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| GSK Investigational Site | Wroclaw | 50-088 | Poland |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107564 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107564 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107564 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107564 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107564 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Elderly subjects aged 65 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix 50-64 Years Group | Adult subjects aged between and including 50-64 years who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
| BG001 | Fluarix 65+ Years Group | Elderly subjects aged 65 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
| BG002 | 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 |
|
| 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 at Least One Influenza-like-infection (ILI) Episode | Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1). | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Influenza-related Complications | ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode). | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | Death due to lab confirmed influenza infection was recorded during the influeza period only. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Fatal Outcomes | Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | RSV infection was determined by the RT-PCR assay. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or 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 and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available. | Posted | Count of Participants | Participants | From Month 0 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Seroconverted Subjects for Each Influenza Strain | A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 21 |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Seroprotected Subjects Against the 3 Influenza Strains | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 0 (PRE) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Seroprotected Subjects Against the 3 Influenza Strains | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Seropositive Subjects for Each Influenza Strain | A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 0 (PRE) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Seropositive Subjects for Each Influenza Strain | A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Serum HI Antibody Titers for Each Influenza Strain | Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 (PRE) |
| |||||||||||||||||||||||||||||||||||
| Primary | Serum HI Antibody Titers for Each Influenza Strain | Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 21 |
|
SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluarix 50-64 Years Group | Adult subjects aged between and including 50-64 years who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 2 | 1,047 | 23 | 1,047 | 0 | 0 |
| EG001 | Fluarix 65+ Years Group | Elderly subjects aged 65 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 10 | 2,007 | 105 | 2,007 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Bleeding varicose vein | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Concussion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematemesis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retinitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient ischemic attack | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
None reported.
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
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
| Male |
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| 2 ILI episodes |
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| >2 ILI episodes |
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Adult subjects aged 50 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
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Adult subjects aged 50 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
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| Fluarix 50+ Years Group |
Adult subjects aged 50 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
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| OG002 | Fluarix 50+ Years Group | Adult subjects aged 50 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
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| Fluarix 50+ Years Group |
Adult subjects aged 50 and over who received a single dose of Fluarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. |
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