Influenza
Conditions
Keywords
vaccine, Influenza
Brief summary
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Interventions
BIOLOGICALInfluenza vaccine GSK2321138A
Intramuscular injection
BIOLOGICALFluarix™
Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 47 Months
Healthy volunteers
Yes
Inclusion criteria
For all subjects: * Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject/from the LAR(s). For unprimed subjects: * A male or female child aged 18 to 47 months at the time of the first vaccination. * Children who did not have influenza vaccine in a previous season. For primed subjects from study NCT00764790: • Children who received Fluarix™ in the 111751 study NCT00764790.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * History of hypersensitivity to any vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s). * Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * Acute disease at the time of enrolment. * History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST] | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | At Days 0 and 28 | A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | At Day 28 | 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 28 | 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | At Days 0 and 28 | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Days 0 and 28. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day follow-up period (Days 0 to 6) after any vaccination | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 28-day follow-up period (Days 0 to 27) after vaccination | An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | From Day 0 to Day 180 (study conclusion) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Adverse Events of Specific Interest (AESIs). | From Day 0 to Day 180 (study conclusion) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day follow-up period (Days 0 to 6) after any vaccination | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
Countries
Mexico
Participant flow
Recruitment details
A total of 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.
Pre-assignment details
For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.
Participants by arm
| Arm | Count |
|---|---|
| GSK2321138A Group Subjects aged between 18 and 47 months received the GSK2321138A. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. | 298 |
| Fluarix Group Subjects aged between 18 and 47 months received the Fluarix™ vaccine. Primed subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. Unprimed subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. | 301 |
| Total | 599 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | GSK2321138A Group | Fluarix Group | Total |
|---|---|---|---|
| Age, Continuous | 31.4 months STANDARD_DEVIATION 8.46 | 31.6 months STANDARD_DEVIATION 8.29 | 31.5 months STANDARD_DEVIATION 8.38 |
| Sex: Female, Male Female | 138 Participants | 147 Participants | 285 Participants |
| Sex: Female, Male Male | 160 Participants | 154 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 230 / 298 | 221 / 301 |
| serious Total, serious adverse events | 0 / 298 | 2 / 301 |
Outcome results
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
Time frame: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H3N2, POST | 120.7 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H3N2, PRE | 18.6 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | VICT, PRE | 8.7 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H1N1, POST | 173.8 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | VICT, POST | 61.9 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H1N1, PRE | 22.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | VICT, POST | 66.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H1N1, PRE | 21.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H3N2, PRE | 20.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H3N2, POST | 130.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | VICT, PRE | 9.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | H1N1, POST | 176.9 titers |
Secondary
Number of Seroconverted Subjects Against 4 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Time frame: At Day 28
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 30 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 48 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 46 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 82 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 40 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 39 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 42 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 46 Participants |
Secondary
Number of Seroconverted Subjects Against 4 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Time frame: At Days 28 and 56
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 63 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 81 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 55 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 79 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 34 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 77 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 59 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 90 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 42 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 74 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 40 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 89 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 40 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 54 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 85 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 75 Participants |
Secondary
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Time frame: At Days 0 and 28
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 58 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 83 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 60 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 88 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 26 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 62 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 73 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 93 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 94 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 54 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 28 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 87 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 80 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 59 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 66 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 87 Participants |
Secondary
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Time frame: At Days 0, 28 and 56
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 75 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 75 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 83 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 99 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 85 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 74 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 99 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 30 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 51 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 96 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 45 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 98 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 57 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 57 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 98 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 71 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 94 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 84 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 42 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 96 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 70 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 82 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 61 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 78 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Time frame: At Days 0 and 28
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 48 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 73 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 39 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 75 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 16 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 50 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 56 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 91 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 90 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 45 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 20 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 78 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 62 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 36 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 52 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 80 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Time frame: At Days 0, 28 and 56
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 58 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 76 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 95 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 74 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 64 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 96 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 25 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 36 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 84 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 37 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 67 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 98 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 53 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 54 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 0 | 35 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 78 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 40 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 94 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 28 | 41 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 70 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 59 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 61 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | VICT, Day 56 | 88 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 94 Participants |
Secondary
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 to Day 180 (study conclusion)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2321138A Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs). | 0 Participants |
| Fluarix Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs). | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 4 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >50 mm | 0 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 125 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 27 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >50 mm | 0 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 31 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >50 mm | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 116 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 1 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 34 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >50 mm | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 24 Participants |
Secondary
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 or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 to Day 180 (study conclusion)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 0 Participants |
| GSK2321138A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 2 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 70 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 2 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 64 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 90 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 4 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 83 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 89 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 4 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 79 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Temperature ≥ 37.5°C | 74 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Temperature > 39.0°C | 3 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature | 63 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Temperature > 39.0°C | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 62 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 86 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 0 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Temperature ≥ 37.5°C | 79 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 57 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 87 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature | 62 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 68 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 78 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.
Time frame: During the 28-day follow-up period (Days 0 to 27) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 7 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AE(s) | 10 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 116 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AE(s) | 12 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 9 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 118 Participants |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Time frame: At Days 28 and 56
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 9.9 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 19.8 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 4.9 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 11.1 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 3.6 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 56 | 11.3 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 9.9 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 35.1 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 3.7 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 12.7 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 3.8 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 19.2 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 3.4 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 5.1 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 56 | 12.1 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 10.3 fold change |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Time frame: At Day 28
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 2.9 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 3.7 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 4.4 fold change |
| GSK2321138A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 8.3 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 3.4 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 3.4 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 4.5 fold change |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 3.8 fold change |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Time frame: At Days 0, 28 and Day 56
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 14.7 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 173.1 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 253.1 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 17.7 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 99.3 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 168.1 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 0 | 7.8 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 26.5 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 56 | 97.2 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 9.1 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 97.0 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 311.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 30.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 0 | 12.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 0 | 8.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 28 | 161.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 9.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1, Day 56 | 249.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 34.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 17.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 56 | 42.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 84.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 56 | 99.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 56 | 202.1 titers |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Time frame: At Days 0 and 28.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1. Day 0 | 40.3 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1. Day 28 | 117.0 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 22.8 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 85.2 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 0 | 8.9 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 38.7 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 29.3 titers |
| GSK2321138A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 243.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 28 | 127.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1. Day 0 | 36.5 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 0 | 9.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H1N1. Day 28 | 124.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | YAMA, Day 0 | 37.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 0 | 21.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | VICT, Day 28 | 44.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | H3N2, Day 28 | 83.0 titers |