Influenza
Conditions
Keywords
Influenza vaccine, Influenza
Brief summary
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALInfluenza Vaccine GSK1247446A
Single dose, intramuscular injection
BIOLOGICALFluarixTM
Single dose, intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials. * Subjects who the investigator believes can and will comply with the requirements of the protocol * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * History of hypersensitivity to a previous dose of influenza vaccine. * History of confirmed influenza infection within the last 12 months. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | During the entire study period (from Day 0 to Day 29) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 30-day (Days 0-29) 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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Day 0 and Day 21 | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10. |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | At Day 21 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | At Day 0 and Day 21 | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Day 21 | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluarix Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 133 |
| GSK1247446A Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 545 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 13 |
Baseline characteristics
| Characteristic | Fluarix Group | GSK1247446A Group | Total |
|---|---|---|---|
| Age, Continuous | 68.1 Years STANDARD_DEVIATION 5.78 | 68.4 Years STANDARD_DEVIATION 5.95 | 68.3 Years STANDARD_DEVIATION 5.91 |
| Sex: Female, Male Female | 82 Participants | 284 Participants | 366 Participants |
| Sex: Female, Male Male | 51 Participants | 261 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 66 / 133 | 434 / 545 |
| serious Total, serious adverse events | 1 / 133 | 2 / 545 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 27 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 2 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 28 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 4 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 16 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 2 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 56 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 282 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 245 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 186 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 14 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 102 subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 1 subjects |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the entire study period (from Day 0 to Day 29)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Related SAE(s) | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s) | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Related SAE(s) | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s) | 2 subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 10 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 7 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 16 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 13 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 15 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 10 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 12 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 6 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 11 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 6 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 8 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 96 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 140 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 3 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 102 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 78 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 152 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 154 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 5 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 116 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 130 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 12 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 35 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 179 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 120 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 29 subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
Time frame: During the 30-day (Days 0-29) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any unsolicited AE(s) | 31 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 unsolicited AE(s) | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related unsolicited AE(s) | 4 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any unsolicited AE(s) | 121 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 unsolicited AE(s) | 9 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related unsolicited AE(s) | 34 subjects |
Secondary
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia | 21 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin | 52 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia | 10 subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia | 78 subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin | 271 subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia | 99 subjects |
Secondary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 0 | 100 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 21 | 119 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 0 | 81 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 21 | 117 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia at Day 0 | 111 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia at Day 21 | 118 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia at Day 0 | 442 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 0 | 381 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 21 | 507 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 21 | 483 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia at Day 21 | 507 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 0 | 397 subjects |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia | 1.7 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin | 3.2 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia | 1.6 fold increase |
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia | 1.9 fold increase |
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin | 4.5 fold increase |
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia | 2.1 fold increase |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 21 | 111.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 21 | 187.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia at Day 0 | 100.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 0 | 65.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia at Day 21 | 158.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 0 | 59.4 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia at Day 21 | 232.4 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 0 | 61.8 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia at Day 21 | 114.4 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 0 | 82.0 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia at Day 0 | 112.1 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin at Day 21 | 370.0 titers |