Influenza
Conditions
Keywords
Immunogenicity, Influenza, Adults, Safety, Elderly
Brief summary
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.
Interventions
BIOLOGICALFluarix/Influsplit Tetra® (2013-2014 season)
1 dose administered intramuscularly in the deltoid region of non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
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. * Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | At Days 0 and 21 | 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). |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | At Day 21 | 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. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | At Day 21 | 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. |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | At Day 21 | 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. |
| Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | At Days 0 and 21 | 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. |
| Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | At Days 0 and 21 | 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. |
| Number of Subjects With Solicited Local Symptoms | During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days) | 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. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | At Day 21 | 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. |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | At Day 21 | 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. |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | At Day 21 | 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. |
| Number of Days of Solicited Local Symptoms | During the entire study period (Days 0 to 21) | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value. |
| Number of Subjects With Solicited General Symptoms | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) | 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. |
| Number of Days of Solicited General Symptoms | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) | 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. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days) | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 57 |
| Total | 117 |
Baseline characteristics
| Characteristic | Fluarix/Influsplit Tetra® Adult Group | Fluarix/Influsplit Tetra® Elderly Group | Total |
|---|---|---|---|
| Age, Continuous | 38.7 Years STANDARD_DEVIATION 12.24 | 70.6 Years STANDARD_DEVIATION 6.81 | 54.24 Years STANDARD_DEVIATION 18.84 |
| Sex: Female, Male Female | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Male | 28 Participants | 26 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 60 | 24 / 57 |
| serious Total, serious adverse events | 0 / 60 | 0 / 57 |
Outcome results
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).
Time frame: At Days 0 and 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56] | 29.8 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56] | 13.1 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] | 151.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] | 58.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] | 505.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 94.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 792.6 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 346.9 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 239.2 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56] | 14.9 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] | 230.3 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56] | 13.5 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 535.0 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] | 110.4 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 77.9 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] | 56.6 Titers |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56] | 17.0 Fold increase |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 5.3 Fold increase |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 7.2 Fold increase |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 5.9 Fold increase |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 4.2 Fold increase |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56] | 15.4 Fold increase |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 5.8 Fold increase |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 4.8 Fold increase |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56] | 48 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 41 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 35 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 37 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 24 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56] | 43 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 32 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 27 Subjects |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56] | 29 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] | 60 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56] | 12 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 54 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] | 56 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 60 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] | 43 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 60 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] | 55 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56] | 12 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] | 52 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] | 49 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] | 40 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56] | 15 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] | 56 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] | 40 Subjects |
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.
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=31,44] | 100 Percentage of subjects |
| Fluarix/Influsplit Tetra® Adult Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=48,41] | 87.5 Percentage of subjects |
| Fluarix/Influsplit Tetra® Adult Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=17, 16] | 100 Percentage of subjects |
| Fluarix/Influsplit Tetra® Adult Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=4,4] | 100 Percentage of subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Brisbane/60/2008 Victoria, Day 21 [N=4,4] | 100 Percentage of subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Christch/16/2010 H1N1, Day 21 [N=31,44] | 84.1 Percentage of subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu B/Mass/2/2012 Yamagata, Day 21 [N=17, 16] | 93.8 Percentage of subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease | Flu A/Texas/50/2012 H3N2, Day 21 [N=48,41] | 61.0 Percentage of subjects |
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.
Time frame: At Days 0 and 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24] | 65.4 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32] | 24.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24] | 21.8 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32] | 11.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24] | 174.4 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32] | 145.6 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24] | 113.2 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32] | 49.6 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 570.2 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 489.9 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 119.9 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 88.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 522.9 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 879.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 269.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 369.7 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 320.0 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24] | 16.1 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 198.6 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32] | 14.1 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 415.2 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24] | 15.0 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 257.4 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32] | 12.6 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 162.2 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24] | 111.6 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 68.2 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32] | 109.5 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 647.0 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24] | 62.7 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 86.1 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32] | 52.4 Titers |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 8.7 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 20.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 5.5 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 7.7 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 3.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 6.0 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 2.4 Titers |
| Fluarix/Influsplit Tetra® Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 7.4 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 6.1 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 12.4 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 3.7 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 18.2 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 2.6 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 4.6 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 5.9 Titers |
| Fluarix/Influsplit Tetra® Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 6.9 Titers |
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.
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Fatigue [N=10;4] | 1.6 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Myalgia [N=14;7] | 1.8 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Arthralgia [N=3;6] | 2.7 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Sweating [N=3;2] | 1.7 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Gastrointestinal symptoms [N=3;2] | 2.0 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Shivering [N=2;0] | 2.0 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited General Symptoms | Headache [N=9;5] | 1.9 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Shivering [N=2;0] | NA Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Arthralgia [N=3;6] | 1.8 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Fatigue [N=10;4] | 2.8 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Headache [N=9;5] | 1.4 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Myalgia [N=14;7] | 2.0 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Sweating [N=3;2] | 2.0 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited General Symptoms | Gastrointestinal symptoms [N=3;2] | 2.5 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.
Time frame: During the entire study period (Days 0 to 21)
Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited Local Symptoms | Induration [N=6;5] | 1.8 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited Local Symptoms | Pain [N=37;19] | 2.2 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited Local Symptoms | Redness [N=3;6] | 2.0 Days |
| Fluarix/Influsplit Tetra® Adult Group | Number of Days of Solicited Local Symptoms | Swelling [N=3;2] | 2.7 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited Local Symptoms | Swelling [N=3;2] | 2.0 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited Local Symptoms | Induration [N=6;5] | 2.2 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited Local Symptoms | Redness [N=3;6] | 1.5 Days |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Days of Solicited Local Symptoms | Pain [N=37;19] | 1.9 Days |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 8 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 40 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 7 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 34 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 32 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 2 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 35 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 20 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 18 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 10 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 25 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 4 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 10 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 22 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 17 Subjects |
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.
Time frame: At Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24] | 9 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32] | 20 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24] | 4 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32] | 8 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24] | 11 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32] | 45 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24] | 11 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32] | 32 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 12 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 48 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 11 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 43 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 12 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 48 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 12 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 48 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] | 32 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24] | 5 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] | 21 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32] | 7 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] | 24 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24] | 7 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] | 28 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32] | 8 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] | 23 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24] | 23 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] | 18 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32] | 29 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] | 32 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24] | 20 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] | 22 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status | Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32] | 20 Subjects |
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.
Time frame: At Days 0 and 21
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Subjects |
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.
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 6 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 9 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 0 Subjects |
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.
Time frame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 8 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 10 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Headache | 9 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Headache | 4 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Myalgia | 14 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Myalgia | 12 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Shivering | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Headache | 5 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Myalgia | 7 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 6 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 4 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 4 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Myalgia | 5 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 2 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms | 2 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms | 1 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Shivering | 2 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited General Symptoms | Related Headache | 4 Subjects |
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.
Time frame: During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Any Induration | 6 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 3 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Subjects |
| Fluarix/Influsplit Tetra® Adult Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 37 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 19 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Any Induration | 5 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 6 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Fluarix/Influsplit Tetra® Elderly Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 2 Subjects |