Influenza
Conditions
Keywords
Southern Hemisphere influenza vaccine, Elderly, Seasonal flu, Fluarix Tetra, Adults, Immunogenicity, Reactogenicity, Influenza
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age).
Interventions
BIOLOGICALFluarix Tetra
One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the 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, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * A male or female aged 18 years or above at the time of vaccination. * Healthy subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering into 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: * 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 the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day -29 to Day 0), or planned use during the study period. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs (e.g. rituximab, infliximab, etc.) within 6 months before study start, or planned administration during the study. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study vaccination and during the entire study period. * Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. * Administration of an influenza vaccine within the 6 months preceding the study start or planned use of such vaccines during the study period.. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 38.0°C/100.4°F, measured by any means. * 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 or chronic, 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 stabilised or clinically serious. * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * History of Guillain-Barré syndrome. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. * History of severe adverse reaction to a previous influenza vaccination. * Anaphylaxis following the administration of vaccine(s). * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | At Days 0 and 21. | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | At Days 0 and 21 | A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Day 21. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | At Day 21 | SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | At Day 21 | MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | During the 4-day (Days 0-3) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 4-day (Days 0-3) post-vaccination period | Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination. |
| Duration of Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Duration was defined as number of days with any grade of local symptoms. |
| Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | At Days 0 and 21 | Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Duration of Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) post-vaccination period. | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period (approximately 21 days for each subject) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | During the entire study period (approximately 21 days for each subject). | MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination. |
| Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | At Days 0 and 21 | A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | At Day 21 | MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Day 21. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | At Day 21 | SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
Countries
Brazil
Participant flow
Pre-assignment details
One subject was allocated the subject number but did not receive the study vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | 63 |
| Fluarix Tetra (Southern Hemisphere) Elderly Group Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | 57 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Migrated/moved from study area | 1 | 0 |
Baseline characteristics
| Characteristic | Fluarix Tetra (Southern Hemisphere) Adult Group | Fluarix Tetra (Southern Hemisphere) Elderly Group | Total |
|---|---|---|---|
| Age, Continuous | 40.8 Years STANDARD_DEVIATION 12.2 | 67.2 Years STANDARD_DEVIATION 6 | 53.3 Years STANDARD_DEVIATION 16.4 |
| Sex: Female, Male Female | 52 Participants | 38 Participants | 90 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 63 | 13 / 57 |
| serious Total, serious adverse events | 0 / 63 | 1 / 57 |
Outcome results
Primary
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21.
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H1N1, Day 0 | 47.3 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H1N1, Day 21 | 460.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H3N2, Day 0 | 32.0 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H3N2, Day 21 | 338.4 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Yamagata, Day 0 | 84.1 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Yamagata, Day 21 | 338.4 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Victoria, Day 0 | 68.8 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Victoria, Day 21 | 365.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Victoria, Day 21 | 288.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H1N1, Day 0 | 31.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Yamagata, Day 0 | 77.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H1N1, Day 21 | 166.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Victoria, Day 0 | 99.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H3N2, Day 0 | 41.7 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | Yamagata, Day 21 | 226.3 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers. | H3N2, Day 21 | 306.7 Titers |
Primary
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 9.7 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 10.6 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 4.0 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 5.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 2.9 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 5.4 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 2.9 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 7.4 Fold increase |
Primary
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21.
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 38 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 49 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 38 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 20 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 35 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 20 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 41 Subjects |
Primary
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 51 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 52 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 59 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 59 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 52 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 52 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 57 Subjects |
Primary
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 40 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 29 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 61 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 48 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 62 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 47 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 54 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 48 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 33 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 57 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 55 Subjects |
Primary
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 22 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 32 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 16 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 14 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 9 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 23 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 10 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 22 Subjects |
Secondary
Duration of Solicited General Symptoms
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Gastrointestinal symptoms [N = 3,0] | 1.0 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Myalgia [N = 9,2] | 2.0 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Sweating [N = 2,0] | 2.5 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Fatigue [N = 6,1] | 3.0 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Shivering [N = 2,0] | 1.5 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Headache [N = 8,1] | 2.5 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited General Symptoms | Arthralgia [N = 6,2] | 1.5 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Myalgia [N = 9,2] | 3.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Arthralgia [N = 6,2] | 2.5 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Fatigue [N = 6,1] | 2.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Gastrointestinal symptoms [N = 3,0] | 0.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Headache [N = 8,1] | 1.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Sweating [N = 2,0] | 0.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited General Symptoms | Shivering [N = 2,0] | 0.0 days |
Secondary
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited Local Symptoms | Pain (N = 27, 13) | 2.0 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited Local Symptoms | Redness (N = 9, 7) | 2.0 days |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Duration of Solicited Local Symptoms | Swelling (N = 7, 6) | 3.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited Local Symptoms | Pain (N = 27, 13) | 1.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited Local Symptoms | Redness (N = 9, 7) | 2.0 days |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Duration of Solicited Local Symptoms | Swelling (N = 7, 6) | 1.5 days |
Secondary
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 0 | 95.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 21 | 282.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 0 | 86.5 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 0 | 41.3 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 21 | 342.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 0 | 133.7 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 21 | 276.7 Titers |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 21 | 306.0 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 21 | 374.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 0 | 49.5 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 21 | 765.3 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 21 | 334.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 0 | 52.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 21 | 473.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 0 | 24.7 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 0 | 25.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 0 | 88.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 0 | 44.8 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 21 | 281.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 0 | 33.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 0 | 114.9 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 21 | 151.8 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 21 | 259.2 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 21 | 194.6 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 21 | 452.5 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 21 | 248.7 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 0 | 31.0 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H3N2, Day 21 | 438.5 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 0 | 45.4 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Yamagata, Day 21 | 425.0 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | Victoria, Day 0 | 54.8 Titers |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies. | H1N1, Day 0 | 22.0 Titers |
Secondary
MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 3.2 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 8.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 2.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Adult Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 3.0 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 13.5 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 7.1 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 9.6 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 29.6 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 2.2 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 6.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 2.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 4.5 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Victoria | 8.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 14.1 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 11.3 Fold increase |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 9.4 Fold increase |
Secondary
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21.
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 14 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 25 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 8 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 14 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 24 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 23 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 24 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 24 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 12 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 33 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 13 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 26 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria | 7 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2 | 8 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1 | 9 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata | 8 Subjects |
Secondary
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 30 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 30 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 28 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 28 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 22 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 21 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 43 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 42 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 0 | 9 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H3N2, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | H1N1, Day 0 | 10 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 0 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Victoria, Day 0 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains. | Yamagata, Day 21 | 11 Subjects |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 27 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 7 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 9 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 3 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 7 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 13 Subjects |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (approximately 21 days for each subject)
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (approximately 21 days for each subject).
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Any MAEs | 4 subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Grade 3 MAEs | 3 subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Related MAEs | 0 subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Any MAEs | 6 subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Grade 3 MAEs | 1 subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Related MAEs | 0 subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 3 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 8 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 9 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 8 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Sweating | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature (Oral) | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Sweating | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 1 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) post-vaccination period.
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicted AEs | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicted AEs | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicted AEs | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicted AEs | 2 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicted AEs | 0 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicted AEs | 10 Subjects |
Secondary
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 27 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 16 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 28 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 27 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 18 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 31 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 21 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 30 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 13 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 13 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 41 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 28 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 44 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 41 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 46 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 27 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 43 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 0 | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H3N2, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | H1N1, Day 0 | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 0 | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 21 | 11 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Victoria, Day 0 | 7 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Yamagata, Day 21 | 11 Subjects |
Secondary
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 15 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 3 Subjects |
| Fluarix Tetra (Southern Hemisphere) Adult Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 17 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 13 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 18 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 10 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 16 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 16 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_Y | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Victoria | 4 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | Yamagata | 5 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H3N2 | 6 Subjects |
| Fluarix Tetra (Southern Hemisphere) Elderly Group_N | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value. | H1N1 | 7 Subjects |