Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.
This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New generation influenza vaccine GSK2186877A Group | Experimental | Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A |
|
| Fluarix elderly Group | Active Comparator | Subjects aged ≥65 years received 1 dose of Fluarix vaccine |
|
| Fluarix young Group | Active Comparator | Subjects aged 18-40 years received 1 dose of Fluarix vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Bio's influenza vaccine GSK2186877A | Biological | Intramuscular (IM) administration, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. | Day 0-6 |
| Duration of Solicited Local AEs | Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm. | 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 >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a 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 adverse event (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 unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 | Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | At Day 0 and 21 |
| HI Antibody Titers at Day 180 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Güglingen | Baden-Wurttemberg | 74363 | Germany | ||
| 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 |
|---|---|---|---|
| 111737 | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A |
| FG001 | Fluarix Elderly Group | Subjects aged ≥65 years received 1 dose of Fluarix vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluarix | Biological | Intramuscular (IM) administration, 1 dose |
|
| Day 0-20 |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination. | Day 0-20 |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination. | Day 21-179 |
| Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) | 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 autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination. | Day 0-179 |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between 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 event assessed by the investigator as causally related to the study vaccination. | Day 0-20 |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 | 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 event assessed by the investigator as causally related to the study vaccination. | Day 21-179 |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 | 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 event assessed by the investigator as causally related to the study vaccination. | Day 180 to Day 209 |
Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| Day 180 |
| The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 | Seropositivity was defined as 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. | At Day 0 and 21 |
| The Number of Subjects Seropositive to HI Antibodies at Day 180 | Seropositivity was defined as 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 180 |
| The Number of Subjects Seroconverted to HI Antibodies at Day 21 | Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 21 |
| The Number of Subjects Seroconverted to HI Antibodies at Day 180 | Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 180 |
| HI Antibody Seroconversion Factor (SCF) at Day 21 | 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. | Day 21 |
| HI Antibody SCF at Day 180 | 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. | Day 180 |
| The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 | Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | At Day 0 and 21 |
| The Number of Subjects Seroprotected to HI Antibodies at Day 180 | Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Day 180 |
| The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 | The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens. | At Day 0 and 21 |
| Mannheim |
| Baden-Wurttemberg |
| 68161 |
| Germany |
| GSK Investigational Site | Rudersberg | Baden-Wurttemberg | 73635 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86150 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | 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 | Freital | Saxony | 01705 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| GSK Investigational Site | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| GSK Investigational Site | Berlin | 10435 | Germany |
| GSK Investigational Site | Berlin | 12627 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Berlin | 13359 | Germany |
| GSK Investigational Site | Hamburg | 22335 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Rotterdam | 3001 DC | Netherlands |
| GSK Investigational Site | Rotterdam | 3011 EN | Netherlands |
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden |
| GSK Investigational Site | Karlskrona | SE-371 41 | Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111737 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Fluarix Young Group | Subjects aged 18-40 years received 1 dose of Fluarix vaccine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A |
| BG001 | Fluarix Elderly Group | Subjects aged ≥65 years received 1 dose of Fluarix vaccine |
| BG002 | Fluarix Young Group | Subjects aged 18-40 years received 1 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 |
|
| 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 was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. | 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 and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm. | 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 >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general 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 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 adverse event (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 unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly 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 Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly 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 Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 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 symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly 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 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) | 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 autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly 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 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between 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 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 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 | 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 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 21-179 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 | 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 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 180 to Day 209 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 | Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 0 and 21 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | HI Antibody Titers at Day 180 | Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 180 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 | Seropositivity was defined as 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 for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21. | Posted | Count of Participants | Participants | At Day 0 and 21 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seropositive to HI Antibodies at Day 180 | Seropositivity was defined as 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) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180. | Posted | Count of Participants | Participants | Day 180 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seroconverted to HI Antibodies at Day 21 | Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21. | Posted | Count of Participants | Participants | Day 21 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seroconverted to HI Antibodies at Day 180 | Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180. | Posted | Count of Participants | Participants | Day 180 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | HI Antibody Seroconversion Factor (SCF) at Day 21 | 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 for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Day 21 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | HI Antibody SCF at Day 180 | 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) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Day 180 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 | Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥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 for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21. | Posted | Count of Participants | Participants | At Day 0 and 21 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects Seroprotected to HI Antibodies at Day 180 | Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥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) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180. | Posted | Count of Participants | Participants | Day 180 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 | The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens. | Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21. | Posted | Geometric Mean | Standard Deviation | cells per million CD4 T-cells | At Day 0 and 21 |
|
Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
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 | New Generation Influenza Vaccine GSK2186877A Group | Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A | 19 | 266 | 160 | 266 | ||
| EG001 | Fluarix Elderly Group | Subjects aged ≥65 years received 1 dose of Fluarix vaccine | 7 | 144 | 39 | 144 | ||
| EG002 | Fluarix Young Group | Subjects aged 18-40 years received 1 dose of Fluarix vaccine | 2 | 116 | 80 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Locked-in syndrome | Nervous system disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Postoperative wound infection | Infections and infestations | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Testicular torsion | Reproductive system and breast disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment | SAE assessed from Day 0 to Day 20. |
| |
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Angina pectoris | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Anoxic encephalopathy | Nervous system disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Arrhythmia | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Atrioventricular block | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Cardiac failure | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Cartilage injury | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Cholecystitis chronic | Hepatobiliary disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Convulsion | Nervous system disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Epididymitis | Reproductive system and breast disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Gastroenteritis norovirus | Infections and infestations | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Glaucoma | Eye disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Incisional hernia | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Large intestine perforation | Gastrointestinal disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Peripheral arterial occlusive disease | Vascular disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Sepsis | Infections and infestations | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Subarachnoid haemorrhage | Nervous system disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE assessed between Day 21 and Day 179. |
| |
| Dysuria | Renal and urinary disorders | Non-systematic Assessment | SAE assessed from Day 180. |
| |
| Embolic cerebral infarction | Nervous system disorders | Non-systematic Assessment | SAE assessed from Day 180. |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE assessed from Day 180. |
| |
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment | SAE assessed from Day 180. |
|
| 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 |
| ||
| Nasopharyngitis | Infections and infestations | Non-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
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
| Male |
|
| Title | Measurements |
|---|---|
|
| Any pain |
|
| Grade 3 pain |
|
| Any redness |
|
| Grade 3 redness |
|
| Any swelling |
|
| Grade 3 swelling |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|