| Primary | 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. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 0 (D0) and at Day 21 (D21) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Victoria Strain FluLaval Group | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | Yamagata Strain FluLaval Group | Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| | Units | Counts |
|---|
| Participants | - OG0001246
- OG001204
- OG002211
|
| | Title | Denominators | Categories |
|---|
| H1N1, D0 | - ParticipantsOG0001238
- ParticipantsOG001204
- ParticipantsOG002211
| |
| |
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | At Day 0 (D0) and at Day 21 (D21) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-64Y Group | Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 65Y Group | Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-60Y Group | Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 61Y Group | Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Medically-attended Adverse Events (MAEs) | Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. | The analysis was performed on the Total Vaccinated cohort, on subjects with available results. | Posted | | Count of Participants | | Participants | | From the beginning of the study until study end (from Day 0 to Day 180) | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Related Medically-attended Adverse Events (MAEs) | Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs. | The analysis was performed on the Total Vaccinated cohort, on subjects with available results. | Posted | | | | | | From the beginning of the study until study end (from Day 0 to Day 180) . | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination. | The analysis was performed on the Total Vaccinated cohort, on subjects with available results. | Posted | | Count of Participants | | Participants | | From the beginning of the study until study end (from Day 0 to Day 180) . | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm |
|
| 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | From the beginning of the study until study end (from Day 0 to Day 180) | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-64Y Group | Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 65Y Group | Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 0 (D0) and at Day 21 (D21) after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Victoria Strain FluLaval Group | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | Yamagata Strain FluLaval Group |
|
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 0 (D0) and at Day 21 (D21) after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-60Y Group | Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 61Y Group | Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 0 (D0) and at Day 21 (D21) after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-64Y Group | Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 65Y Group | Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | 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/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 21 (D21) after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-64Y Group | Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 65Y Group | Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 21 (D21) after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-64Y Group | Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 65Y Group | Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | At Day 0 (D0) and at Day 21 (D21) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-60Y Group | Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 61Y Group | Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| 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. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. | The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Victoria Strain FluLaval Group | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | Yamagata Strain FluLaval Group |
|
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza | 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/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 21 (D21) after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Victoria Strain FluLaval Group | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | |
|
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | 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/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Count of Participants | | Participants | | At Day 21 (D21) after vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-60Y Group | Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 61Y Group | Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 21 (D21) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 18-60Y Group | Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A ≥ 61Y Group | Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 21 (D21) post vaccination. | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | Victoria Strain FluLaval Group | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| 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. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available. | Posted | | Count of Participants | | Participants | | Within the 7-day (Days 0-6) follow-up period after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available. | Posted | | Count of Participants | | Participants | | Within the 7-day (Days 0-6) follow-up period after vaccination | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | | Count of Participants | | Participants | | Within the 21-day (Days 0-20) follow-up period after vaccination | | | | ID | Title | Description |
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| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Days With Solicited Local Symptoms After Vaccination. | Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available. | Posted | | | | | | Within the 7-day follow-up period after vaccination (Days 0-6) | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG003 |
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| Secondary | Number of Days With Solicited General Symptoms After Vaccination | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available. | Posted | | | | | | Within the 7-day follow-up period after vaccination (Days 0-6) | | | | ID | Title | Description |
|---|
| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
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| Secondary | Number of Days With Unsolicited Adverse Events (AEs) After Vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | | | | | | Within the 21-day (Days 0-20) follow-up period post vaccination | | | | ID | Title | Description |
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| OG000 | GSK2282512A 1 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG001 | GSK2282512A 2 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | | OG002 | GSK2282512A 3 Group | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
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