Influenza, Influenza, Human
Conditions
Keywords
Influenza, Influenza vaccine
Brief summary
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
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
BIOLOGICALFluarix™
Single dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two 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 within 30 days preceding the administration of the study vaccine, or planned use during the study period. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period * Previous vaccination against influenza since January 2007. * Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Chronic administration of immunosuppressants or other immune-modifying drugs within three 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 three months preceding the dose of study vaccine or planned administration during the study period. * History of hypersensitivity to a previous dose of influenza vaccine. * History of confirmed influenza infection within the last 12 months. * Pregnancy. * 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 (Days 0-30) | Serious adverse events (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. Related = SAE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | During a 7-day (Days 0-6) follow-up period after re-vaccination | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During a 7-day (Days 0-6) follow-up after re-vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 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 a 30-day (Days 0-29) follow-up period after re-vaccination | 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 study vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | At Day 0 and 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| Seroconversion Factor for 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
Countries
Belgium
Participant flow
Recruitment details
Subjects enrolled and vaccinated in this NCT00545025 follow-up previously participated in the NCT00374842 study, wherein they were vaccinated with either the GSK1247446A or Fluarix™ vaccines.
Pre-assignment details
Subjects were allocated to study groups based on their vaccination course in the NCT00374842 primary study, so as to receive a re-vaccination dose of the vaccine previously administered.
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A Group Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. | 160 |
| Fluarix Group Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. | 83 |
| Total | 243 |
Baseline characteristics
| Characteristic | GSK1247446A Group | Fluarix Group | Total |
|---|---|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 13.66 | 40.9 Years STANDARD_DEVIATION 13.66 | 39.9 Years STANDARD_DEVIATION 13.66 |
| Sex: Female, Male Female | 98 Participants | 44 Participants | 142 Participants |
| Sex: Female, Male Male | 62 Participants | 39 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 83 |
| other Total, other adverse events | 143 / 160 | 57 / 83 |
| serious Total, serious adverse events | 0 / 160 | 1 / 83 |
Outcome results
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (Days 0-30)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time frame: During a 7-day (Days 0-6) follow-up after re-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 28 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 Arthralgia | 26 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 72 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 7 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 71 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥37.5°C | 27 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >39.0°C | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 27 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 65 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 6 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 61 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 56 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 4 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 52 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 23 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 21 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 39 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 4 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 39 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 5 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 3 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 Headache | 16 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 5 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 0 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 12 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 8 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 10 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥37.5°C | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 3 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >39.0°C | 0 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 8 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 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. | Any Headache | 18 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 4 Subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Time frame: During a 7-day (Days 0-6) follow-up period after re-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Ecchymosis | 8 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Ecchymosis > 50mm | 1 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain | 143 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain | 9 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness | 24 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Redness > 50mm | 2 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling | 29 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Swelling > 50mm | 4 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Swelling > 50mm | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Ecchymosis | 5 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness | 10 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Ecchymosis > 50mm | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling | 13 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain | 57 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Redness > 50mm | 1 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain | 2 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 study vaccination.
Time frame: During a 30-day (Days 0-29) follow-up period after re-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 69 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 16 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 35 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 31 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 10 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 8 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Time frame: At Day 21
Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/SOL | 73 Subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/WIS | 40 Subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/MAL | 61 Subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/SOL | 30 Subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/WIS | 13 Subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/MAL | 23 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Time frame: At Day 0 and 21
Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/SOL, Day 0 [N=158, 82] | 87 Subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/SOL, Day 21 [159, 82] | 155 Subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/WIS, Day 0 [N=158, 82] | 139 Subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/WIS, Day 21 [N=159, 82] | 159 Subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/MAL, Day 0 [N=158, 82] | 133 Subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/MAL, Day 21 [N=159, 82] | 159 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/MAL, Day 0 [N=158, 82] | 67 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/SOL, Day 0 [N=158, 82] | 45 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/WIS, Day 21 [N=159, 82] | 80 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/SOL, Day 21 [159, 82] | 75 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/MAL, Day 21 [N=159, 82] | 82 Subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/WIS, Day 0 [N=158, 82] | 69 Subjects |
Secondary
Seroconversion Factor for 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Time frame: At Day 21
Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | A/SOL | 3.9 Fold increase |
| GSK1247446A Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | A/WIS | 2.3 Fold increase |
| GSK1247446A Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | B/MAL | 3.1 Fold increase |
| Fluarix Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | A/SOL | 3.0 Fold increase |
| Fluarix Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | A/WIS | 1.9 Fold increase |
| Fluarix Group | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. | B/MAL | 2.6 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.
Time frame: At Days 0 and 21
Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/SOL, Day 0 [N=158, 82] | 41.0 Titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/SOL, Day 21 [N=159, 82] | 162.4 Titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/WIS, Day 0 [N=158, 82] | 83.2 Titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/WIS, Day 21 [N=159, 82] | 191.7 Titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/MAL, Day 0 [N=158, 82] | 107.3 Titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/MAL, Day 21 [N=159, 82] | 334.2 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/MAL, Day 0 [N=158, 82] | 75.7 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/SOL, Day 0 [N=158, 82] | 43.0 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/WIS, Day 21 [N=159, 82] | 147.0 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/SOL, Day 21 [N=159, 82] | 127.2 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/MAL, Day 21 [N=159, 82] | 199.3 Titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/WIS, Day 0 [N=158, 82] | 78.9 Titer |