Influenza
Conditions
Keywords
Influenza vaccine, Prophylaxis Influenza vaccine
Brief summary
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Interventions
BIOLOGICALFluarix™
GlaxoSmithKline Biologicals' licensed influenza vaccine
BIOLOGICALGSK1247446A
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female aged 18-59 years at the time of the first vaccination. * Free of obvious health problems
Exclusion criteria
* Use of non-registered products * Administration of immune-modifying drugs. * Administration of vaccine 30 days before enrolment in study. * Immunosuppressive or immunodeficient condition. * Hypersensitivity to a previous dose of influenza vaccine * Previous vaccination against influenza in 2006 * Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality. * History of confirmed influenza infection within the last 12 Months. * Acute disease at the time of enrolment/vaccination. * History of allergy or reactions likely to be exacerbated by any component of the vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | At Day 21. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]). |
| Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | At Day 0 and at Day 21. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU. |
| Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | At Day 0 and at Day 21. | A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen). |
| Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | At Day 21. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 7-day follow-up period (Days 0-6) after vaccination | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (\>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day follow-up period (Days 0-6) after vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (\>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 30-day follow-up period (Days 0-29) after vaccination | An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From study start to study end, from Day 0 to Day 30 | 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 = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination. |
Countries
Belgium
Participant flow
Recruitment details
A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A Formulation 1 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 100 |
| GSK1247446A Formulation 2 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 100 |
| Fluarix Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | GSK1247446A Formulation 1 Group | GSK1247446A Formulation 2 Group | Fluarix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 37.3 Years STANDARD_DEVIATION 13.94 | 35.0 Years STANDARD_DEVIATION 13.26 | 37.7 Years STANDARD_DEVIATION 13.75 | 36.7 Years STANDARD_DEVIATION 13.65 |
| Sex: Female, Male Female | 65 Participants | 60 Participants | 57 Participants | 182 Participants |
| Sex: Female, Male Male | 35 Participants | 40 Participants | 43 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 98 / 100 | 95 / 100 | 81 / 100 |
| serious Total, serious adverse events | 1 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer.
Time frame: At Day 21.
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/WIS, Day 21 | 88 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/CAL, Day 21 | 69 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | B/MAL, Day 21 | 76 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/WIS, Day 21 | 79 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/CAL, Day 21 | 64 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | B/MAL, Day 21 | 82 Subject |
| Fluarix Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/CAL, Day 21 | 66 Subject |
| Fluarix Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | B/MAL, Day 21 | 65 Subject |
| Fluarix Group | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | A/WIS, Day 21 | 73 Subject |
Primary
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Time frame: At Day 0 and at Day 21.
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 41 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 95 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 32 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 97 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 31 Subject |
| GSK1247446A Formulation 1 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 97 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 98 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 55 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 97 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 39 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 97 Subject |
| GSK1247446A Formulation 2 Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 37 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 93 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 25 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 94 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 93 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 35 Subject |
| Fluarix Group | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 44 Subject |
Primary
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).
Time frame: At Day 21.
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 16.5 Fold increase |
| GSK1247446A Formulation 1 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 14.9 Fold increase |
| GSK1247446A Formulation 1 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 13.2 Fold increase |
| GSK1247446A Formulation 2 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 12.2 Fold increase |
| GSK1247446A Formulation 2 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 11.0 Fold increase |
| GSK1247446A Formulation 2 Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 13.6 Fold increase |
| Fluarix Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 14.6 Fold increase |
| Fluarix Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 8.3 Fold increase |
| Fluarix Group | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 11.7 Fold increase |
Primary
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Time frame: At Day 0 and at Day 21.
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 31.9 HIU |
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 475.4 HIU |
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 16.8 HIU |
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 276.2 HIU |
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 20.4 HIU |
| GSK1247446A Formulation 1 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 268.6 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 301.5 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 36.1 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 241.9 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 22.2 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 399.0 HIU |
| GSK1247446A Formulation 2 Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 19.9 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 21 | 380.6 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 0 | 14.7 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 21 | 219.2 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/WIS, Day 21 | 172.3 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | A/CAL, Day 0 | 26.1 HIU |
| Fluarix Group | Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | B/MAL, Day 0 | 26.5 HIU |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (\>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Time frame: Within the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 6 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis (> 50 mm) | 0 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain | 92 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 10 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness | 24 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness (> 50 mm) | 6 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling | 28 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling (> 50 mm) | 7 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain | 89 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling | 17 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 0 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness | 12 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness (> 50 mm) | 2 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 11 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis (> 50 mm) | 0 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling (> 50 mm) | 4 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain | 64 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis (> 50 mm) | 0 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 6 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 0 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling | 7 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness (> 50 mm) | 1 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness | 15 Subject |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling (> 50 mm) | 2 Subject |
Secondary
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 = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Time frame: From study start to study end, from Day 0 to Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with any SAE(s) | 1 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with related SAE(s) | 0 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with any SAE(s) | 0 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with related SAE(s) | 0 Subject |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with any SAE(s) | 0 Subject |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with related SAE(s) | 0 Subject |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (\>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Time frame: Within the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 6 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 32 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 3 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 32 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 60 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 59 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Axillary fever (>= 37.5°C) | 30 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 axillary fever (> 39.0°C) | 2 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related axillary fever (>= 37.5°C) | 30 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 51 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 9 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 50 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 48 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 4 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 47 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 33 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 2 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 33 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 13 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 30 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 14 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 40 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 1 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 29 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 2 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 13 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 13 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 2 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 42 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 6 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related axillary fever (>= 37.5°C) | 12 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 2 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 axillary fever (> 39.0°C) | 0 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 35 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 39 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Axillary fever (>= 37.5°C) | 12 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 26 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Axillary fever (>= 37.5°C) | 2 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 axillary fever (> 39.0°C) | 0 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 11 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related axillary fever (>= 37.5°C) | 2 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 5 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 29 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 3 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 5 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 23 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 12 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 0 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 5 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 28 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 7 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 1 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 0 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 0 Subject |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: Within the 30-day follow-up period (Days 0-29) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 unsolicited AE(s) | 11 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with any unsolicited AE(s) | 55 Subject |
| GSK1247446A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with related unsolicited AE(s) | 33 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 unsolicited AE(s) | 5 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with any unsolicited AE(s) | 47 Subject |
| GSK1247446A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with related unsolicited AE(s) | 22 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with any unsolicited AE(s) | 35 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with related unsolicited AE(s) | 16 Subject |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 unsolicited AE(s) | 6 Subject |