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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001094-25 | EudraCT Number |
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The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains and two B strains) for the 2013/2014 season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Experimental | Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Fluarix/Influsplit Tetra® Elderly Group | Experimental | Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix/Influsplit Tetra® (2013-2014 season) | Biological | 1 dose administered intramuscularly in the deltoid region of non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). | At Days 0 and 21 |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. | At Day 21 |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. | At Day 21 |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. | At Day 21 |
| Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
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Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Participation in previous year's Fluarix registration study (116663).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
Administration of an influenza vaccine within the twelve months preceding the study vaccination.
Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
Acute disease and/or fever at the time of enrollment.
Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
History of chronic alcohol consumption and/or drug abuse.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of Guillain-Barré syndrome.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
Anaphylaxis following the administration of vaccine(s).
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluarix/Influsplit Tetra® Adult Group | Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | Fluarix/Influsplit Tetra® Elderly Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. |
| During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
| During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days) |
| Number of Days of Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value. | During the entire study period (Days 0 to 21) |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
| Number of Days of Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value. | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
| Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | At Days 0 and 21 |
| Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | At Days 0 and 21 |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | At Day 21 |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | At Day 21 |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | At Day 21 |
| Dresden |
| Saxony |
| 01099 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01309 | Germany |
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix/Influsplit Tetra® Adult Group | Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | Fluarix/Influsplit Tetra® Elderly Group | Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| 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 | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 and 21 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Number | Subjects | At Day 21 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Number | Subjects | At Day 21 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Number | Percentage of subjects | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site. | Posted | Number | Subjects | During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days of Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value. | The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported. | Posted | Mean | Inter-Quartile Range | Days | During the entire study period (Days 0 to 21) |
|
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Posted | Number | Subjects | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days of Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value. | The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported. | Posted | Mean | Inter-Quartile Range | Days | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | Posted | Number | Subjects | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) |
|
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| Secondary | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Posted | Number | Subjects | At Days 0 and 21 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 and 21 |
|
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| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Number | Subjects | At Day 21 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Number | Subjects | At Day 21 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season. | The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 21 |
|
Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
Not provided
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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/Influsplit Tetra® Adult Group | Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. | 0 | 60 | 46 | 60 | ||
| EG001 | Fluarix/Influsplit Tetra® Elderly Group | Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. | 0 | 57 | 24 | 57 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Redness | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | General disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | General disorders | MedDRA | Systematic Assessment |
| |
| Sweating | General disorders | MedDRA | 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 |
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| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
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| Male |
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| Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] |
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| Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] |
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| Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] |
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| Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] |
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| Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] |
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| Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] |
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| Participants |
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