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The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarixâ„¢ administered intramuscularly in elderly aged 60 years and above
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix Group | Active Comparator | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarixâ„¢ vaccine in study NCT00321763, received 1 dose of Fluarixâ„¢ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK1247446A Group | Experimental | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine GSK1247446A | Biological | Single dose, intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm). | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination. | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination. | During the 30-day (Days 0-29) post vaccination period |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10. | At Day 0 and Day 21 |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
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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 | Elverum | 2408 | Norway | |||
| 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 |
|---|---|---|---|
| 108708 | 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 | Fluarix Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarixâ„¢ vaccine in study NCT00321763, received 1 dose of Fluarixâ„¢ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarixâ„¢ vaccine in study NCT00321763, received 1 dose of Fluarixâ„¢ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed. | Posted | Number | subjects | During the 7-day (Days 0-6) post-vaccination period |
|
SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period.
For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been 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 | Fluarix Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarixâ„¢ vaccine in study NCT00321763, received 1 dose of Fluarixâ„¢ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| FluarixTM |
| Biological |
Single dose, intramuscular injection |
|
| During the entire study period (from Day 0 to Day 29) |
A seroconverted subject was defined as a vaccinated 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 four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| At Day 21 |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. | At Day 0 and 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 Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. | At Day 21 |
| Hamar |
| 2301 |
| Norway |
| GSK Investigational Site | Paradis | 5231 | Norway |
| GSK Investigational Site | Stavanger | 4010 | Norway |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108708 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108708 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108708 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108708 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108708 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GSK1247446A Group |
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed. | Posted | Number | subjects | During the 7-day (Days 0-6) post-vaccination period |
|
|
|
| Primary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the 30-day (Days 0-29) post vaccination period |
|
|
|
| Primary | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the entire study period (from Day 0 to Day 29) |
|
|
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10. | The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 0 and Day 21 |
|
|
|
| Secondary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated 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 four-fold increase in post-vaccination titer. 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, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component. | Posted | Number | subjects | At Day 21 |
|
|
|
| Secondary | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. 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, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component. | Posted | Number | subjects | At Day 0 and Day 21 |
|
|
|
| Secondary | 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 Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination 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, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component. | Posted | Mean | 95% Confidence Interval | fold increase | At Day 21 |
|
|
|
| 1 |
| 133 |
| 66 |
| 133 |
| EG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 2 | 545 | 434 | 545 |
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sudden death | General disorders | Non-systematic Assessment |
|
| 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 |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Muscle aches | 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Related Arthralgia |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Related Fatigue |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Muscle aches |
|
| Grade 3 Muscle aches |
|
| Related Muscle aches |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
| Related unsolicited AE(s) |
|
| A/Wisconsin at Day 0 |
|
| A/Wisconsin at Day 21 |
|
| B/Malaysia at Day 0 |
|
| B/Malaysia at Day 21 |
|
| B/Malaysia |
|
| A/Wisconsin at Day 0 |
|
| A/Wisconsin at Day 21 |
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| B/Malaysia at Day 0 |
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| B/Malaysia at Day 21 |
|
| B/Malaysia |
|